hydrocodone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 1386 | 125-29-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Narcotic analgesic related to CODEINE, but more potent and more addicting by weight. It is used also as cough suppressant.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 15 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 62.50 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 10.20 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 2.15 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 80 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 23, 1943 | FDA | ENDO PHARMS |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Completed suicide | 937.34 | 10.62 | 879 | 55677 | 144794 | 63287672 |
| Cholecystitis chronic | 465.18 | 10.62 | 213 | 56343 | 10148 | 63422318 |
| Toxicity to various agents | 392.97 | 10.62 | 751 | 55805 | 246499 | 63185967 |
| Drug hypersensitivity | 269.44 | 10.62 | 743 | 55813 | 309944 | 63122522 |
| Cardio-respiratory arrest | 254.55 | 10.62 | 290 | 56266 | 59669 | 63372797 |
| Emotional distress | 198.29 | 10.62 | 191 | 56365 | 32358 | 63400108 |
| Cholelithiasis | 178.88 | 10.62 | 208 | 56348 | 43717 | 63388749 |
| Respiratory arrest | 177.40 | 10.62 | 180 | 56376 | 32465 | 63400001 |
| Contraindicated product administered | 170.91 | 10.62 | 5 | 56551 | 217643 | 63214823 |
| Drug abuse | 166.98 | 10.62 | 260 | 56296 | 72258 | 63360208 |
| Gallbladder disorder | 165.45 | 10.62 | 136 | 56420 | 18706 | 63413760 |
| Anxiety | 157.25 | 10.62 | 488 | 56068 | 217053 | 63215413 |
| Injury | 151.37 | 10.62 | 250 | 56306 | 72997 | 63359469 |
| Deep vein thrombosis | 141.91 | 10.62 | 262 | 56294 | 83538 | 63348928 |
| Maternal exposure during pregnancy | 137.75 | 10.62 | 17 | 56539 | 220045 | 63212421 |
| Drug intolerance | 133.50 | 10.62 | 54 | 56502 | 308607 | 63123859 |
| Hand deformity | 123.93 | 10.62 | 4 | 56552 | 159453 | 63273013 |
| Synovitis | 123.16 | 10.62 | 12 | 56544 | 186906 | 63245560 |
| Depression | 121.43 | 10.62 | 418 | 56138 | 196074 | 63236392 |
| Glossodynia | 119.13 | 10.62 | 11 | 56545 | 178865 | 63253601 |
| Systemic lupus erythematosus | 115.25 | 10.62 | 23 | 56533 | 208895 | 63223571 |
| Off label use | 113.42 | 10.62 | 273 | 56283 | 674189 | 62758277 |
| Infusion related reaction | 109.35 | 10.62 | 41 | 56515 | 245480 | 63186986 |
| Treatment failure | 105.52 | 10.62 | 24 | 56532 | 199019 | 63233447 |
| Intentional product misuse | 105.05 | 10.62 | 192 | 56364 | 60725 | 63371741 |
| Biliary dyskinesia | 100.62 | 10.62 | 49 | 56507 | 2680 | 63429786 |
| Pericarditis | 93.49 | 10.62 | 6 | 56550 | 131573 | 63300893 |
| Lower respiratory tract infection | 88.45 | 10.62 | 8 | 56548 | 132299 | 63300167 |
| Wound | 80.15 | 10.62 | 23 | 56533 | 163240 | 63269226 |
| Joint swelling | 79.84 | 10.62 | 105 | 56451 | 327561 | 63104905 |
| Gallbladder injury | 79.11 | 10.62 | 34 | 56522 | 1389 | 63431077 |
| Pulmonary embolism | 78.89 | 10.62 | 256 | 56300 | 116428 | 63316038 |
| Cardiac arrest | 78.55 | 10.62 | 220 | 56336 | 92325 | 63340141 |
| Drug ineffective | 77.03 | 10.62 | 581 | 55975 | 1044184 | 62388282 |
| Death | 76.13 | 10.62 | 582 | 55974 | 373799 | 63058667 |
| Discomfort | 74.40 | 10.62 | 28 | 56528 | 167346 | 63265120 |
| Drug withdrawal syndrome | 70.36 | 10.62 | 103 | 56453 | 27091 | 63405375 |
| Product use issue | 64.26 | 10.62 | 61 | 56495 | 220459 | 63212007 |
| Arthropathy | 63.81 | 10.62 | 69 | 56487 | 234723 | 63197743 |
| Accidental overdose | 62.80 | 10.62 | 90 | 56466 | 23219 | 63409247 |
| Accidental death | 62.58 | 10.62 | 32 | 56524 | 1944 | 63430522 |
| Rheumatoid factor positive | 62.57 | 10.62 | 3 | 56553 | 84403 | 63348063 |
| Helicobacter infection | 60.97 | 10.62 | 6 | 56550 | 92779 | 63339687 |
| Hepatic enzyme increased | 58.91 | 10.62 | 56 | 56500 | 202272 | 63230194 |
| Inadequate analgesia | 58.34 | 10.62 | 35 | 56521 | 2908 | 63429558 |
| Drug dependence | 58.01 | 10.62 | 89 | 56467 | 24394 | 63408072 |
| Overdose | 57.71 | 10.62 | 229 | 56327 | 114849 | 63317617 |
| C-reactive protein increased | 57.57 | 10.62 | 8 | 56548 | 94699 | 63337767 |
| Abdominal discomfort | 53.63 | 10.62 | 130 | 56426 | 320755 | 63111711 |
| Rash | 53.37 | 10.62 | 288 | 56268 | 560583 | 62871883 |
| Exposure during pregnancy | 51.49 | 10.62 | 38 | 56518 | 155509 | 63276957 |
| Drug abuser | 48.40 | 10.62 | 31 | 56525 | 2892 | 63429574 |
| Anhedonia | 48.08 | 10.62 | 54 | 56502 | 10920 | 63421546 |
| Muscle injury | 46.34 | 10.62 | 3 | 56553 | 65342 | 63367124 |
| Therapeutic product effect decreased | 44.89 | 10.62 | 64 | 56492 | 193123 | 63239343 |
| Coronary artery disease | 43.60 | 10.62 | 92 | 56464 | 32285 | 63400181 |
| Back pain | 43.08 | 10.62 | 391 | 56165 | 263754 | 63168712 |
| Gallbladder hypofunction | 42.97 | 10.62 | 17 | 56539 | 561 | 63431905 |
| Mental status changes | 42.69 | 10.62 | 103 | 56453 | 39496 | 63392970 |
| Folliculitis | 42.59 | 10.62 | 6 | 56550 | 70311 | 63362155 |
| Nasopharyngitis | 42.47 | 10.62 | 103 | 56453 | 254154 | 63178312 |
| Biliary colic | 42.41 | 10.62 | 31 | 56525 | 3586 | 63428880 |
| Condition aggravated | 41.91 | 10.62 | 200 | 56356 | 402017 | 63030449 |
| Cholecystitis | 40.87 | 10.62 | 59 | 56497 | 15318 | 63417148 |
| Neutropenia | 40.63 | 10.62 | 58 | 56498 | 174947 | 63257519 |
| Hypersensitivity | 40.41 | 10.62 | 130 | 56426 | 292555 | 63139911 |
| Scar | 39.77 | 10.62 | 55 | 56501 | 13727 | 63418739 |
| Alopecia | 39.28 | 10.62 | 161 | 56395 | 337375 | 63095091 |
| Cerebrovascular accident | 37.63 | 10.62 | 193 | 56363 | 107831 | 63324635 |
| Swelling | 35.49 | 10.62 | 126 | 56430 | 275252 | 63157214 |
| Insomnia | 35.27 | 10.62 | 319 | 56237 | 214933 | 63217533 |
| Rheumatoid arthritis | 34.84 | 10.62 | 113 | 56443 | 253706 | 63178760 |
| Respiratory depression | 34.11 | 10.62 | 51 | 56505 | 13664 | 63418802 |
| Infection | 33.60 | 10.62 | 99 | 56457 | 229074 | 63203392 |
| Cholesterosis | 32.49 | 10.62 | 13 | 56543 | 442 | 63432024 |
| Pyrexia | 32.38 | 10.62 | 266 | 56290 | 470212 | 62962254 |
| Acute lung injury | 31.96 | 10.62 | 19 | 56537 | 1552 | 63430914 |
| Febrile neutropenia | 31.94 | 10.62 | 35 | 56521 | 118414 | 63314052 |
| Intervertebral disc protrusion | 31.49 | 10.62 | 67 | 56489 | 23642 | 63408824 |
| Feeling abnormal | 31.35 | 10.62 | 233 | 56323 | 148159 | 63284307 |
| Gallbladder cholesterolosis | 31.31 | 10.62 | 15 | 56541 | 791 | 63431675 |
| Nausea | 30.80 | 10.62 | 986 | 55570 | 853485 | 62578981 |
| Sleep disorder due to general medical condition, insomnia type | 30.38 | 10.62 | 5 | 56551 | 52212 | 63380254 |
| Chest pain | 29.93 | 10.62 | 309 | 56247 | 215650 | 63216816 |
| Muscle spasms | 29.01 | 10.62 | 238 | 56318 | 155912 | 63276554 |
| Liver injury | 28.82 | 10.62 | 9 | 56547 | 60511 | 63371955 |
| Musculoskeletal stiffness | 28.34 | 10.62 | 78 | 56478 | 184540 | 63247926 |
| Drug screen positive | 27.35 | 10.62 | 24 | 56532 | 3605 | 63428861 |
| Dependence | 27.11 | 10.62 | 19 | 56537 | 2058 | 63430408 |
| Ill-defined disorder | 27.01 | 10.62 | 20 | 56536 | 81735 | 63350731 |
| Poisoning | 25.93 | 10.62 | 45 | 56511 | 13655 | 63418811 |
| Pain in extremity | 25.56 | 10.62 | 426 | 56130 | 331060 | 63101406 |
| Intervertebral disc degeneration | 25.12 | 10.62 | 48 | 56508 | 15684 | 63416782 |
| Dehydration | 24.46 | 10.62 | 249 | 56307 | 173105 | 63259361 |
| Product use in unapproved indication | 23.68 | 10.62 | 81 | 56475 | 178999 | 63253467 |
| Uterine perforation | 23.49 | 10.62 | 30 | 56526 | 6933 | 63425533 |
| Mental disorder | 23.34 | 10.62 | 63 | 56493 | 25856 | 63406610 |
| Thrombosis | 22.75 | 10.62 | 116 | 56440 | 64639 | 63367827 |
| Abnormal dreams | 21.84 | 10.62 | 36 | 56520 | 10480 | 63421986 |
| Fall | 21.32 | 10.62 | 478 | 56078 | 391856 | 63040610 |
| Thrombocytopenia | 20.93 | 10.62 | 67 | 56489 | 151090 | 63281376 |
| Cardiac failure | 20.23 | 10.62 | 30 | 56526 | 89112 | 63343354 |
| Migraine | 19.99 | 10.62 | 159 | 56397 | 103187 | 63329279 |
| Coagulopathy | 19.58 | 10.62 | 51 | 56505 | 20493 | 63411973 |
| Chronic obstructive pulmonary disease | 19.11 | 10.62 | 108 | 56448 | 62578 | 63369888 |
| Metabolic acidosis | 18.92 | 10.62 | 85 | 56471 | 44984 | 63387482 |
| Peripheral swelling | 18.88 | 10.62 | 149 | 56407 | 265793 | 63166673 |
| Cholecystectomy | 18.83 | 10.62 | 34 | 56522 | 10643 | 63421823 |
| Psoriatic arthropathy | 18.70 | 10.62 | 33 | 56523 | 91487 | 63340979 |
| Back injury | 18.64 | 10.62 | 32 | 56524 | 9628 | 63422838 |
| Withdrawal syndrome | 18.40 | 10.62 | 49 | 56507 | 19948 | 63412518 |
| Blister | 18.35 | 10.62 | 57 | 56499 | 129757 | 63302709 |
| Gamma-glutamyltransferase increased | 18.22 | 10.62 | 4 | 56552 | 34027 | 63398439 |
| Cholecystitis acute | 18.14 | 10.62 | 29 | 56527 | 8231 | 63424235 |
| Fear | 18.06 | 10.62 | 42 | 56514 | 15724 | 63416742 |
| Neck injury | 17.97 | 10.62 | 15 | 56541 | 2106 | 63430360 |
| Renal impairment | 17.93 | 10.62 | 32 | 56524 | 88323 | 63344143 |
| Restless legs syndrome | 17.66 | 10.62 | 46 | 56510 | 18485 | 63413981 |
| Purpura senile | 17.49 | 10.62 | 9 | 56547 | 554 | 63431912 |
| Tarsal tunnel syndrome | 17.32 | 10.62 | 9 | 56547 | 565 | 63431901 |
| Respiratory muscle weakness | 17.24 | 10.62 | 6 | 56550 | 137 | 63432329 |
| Interstitial lung disease | 17.01 | 10.62 | 18 | 56538 | 61890 | 63370576 |
| Red blood cell sedimentation rate increased | 16.95 | 10.62 | 9 | 56547 | 43973 | 63388493 |
| Hepatic function abnormal | 16.85 | 10.62 | 6 | 56550 | 37136 | 63395330 |
| Impaired healing | 16.73 | 10.62 | 42 | 56514 | 102500 | 63329966 |
| General physical health deterioration | 16.64 | 10.62 | 108 | 56448 | 201294 | 63231172 |
| Leukopenia | 16.59 | 10.62 | 27 | 56529 | 77263 | 63355203 |
| Tooth loss | 16.35 | 10.62 | 25 | 56531 | 6831 | 63425635 |
| Myocardial infarction | 16.31 | 10.62 | 148 | 56408 | 99745 | 63332721 |
| Abortion spontaneous | 16.30 | 10.62 | 11 | 56545 | 47184 | 63385282 |
| Memory impairment | 16.28 | 10.62 | 153 | 56403 | 104105 | 63328361 |
| Stomatitis | 16.21 | 10.62 | 66 | 56490 | 138659 | 63293807 |
| Peptic ulcer | 15.85 | 10.62 | 20 | 56536 | 4567 | 63427899 |
| Gastrooesophageal reflux disease | 15.77 | 10.62 | 142 | 56414 | 95497 | 63336969 |
| Emotional disorder | 15.72 | 10.62 | 36 | 56520 | 13343 | 63419123 |
| Wheezing | 15.72 | 10.62 | 39 | 56517 | 95556 | 63336910 |
| Cardiac failure congestive | 15.63 | 10.62 | 138 | 56418 | 92295 | 63340171 |
| Brain death | 15.32 | 10.62 | 17 | 56539 | 3393 | 63429073 |
| Device expulsion | 15.24 | 10.62 | 6 | 56550 | 34916 | 63397550 |
| Blood pressure systolic increased | 15.13 | 10.62 | 12 | 56544 | 47385 | 63385081 |
| Hepatocellular injury | 15.11 | 10.62 | 3 | 56553 | 27378 | 63405088 |
| Toxic leukoencephalopathy | 15.06 | 10.62 | 9 | 56547 | 742 | 63431724 |
| Irritable bowel syndrome | 14.86 | 10.62 | 32 | 56524 | 82380 | 63350086 |
| Lumbosacral plexopathy | 14.78 | 10.62 | 3 | 56553 | 6 | 63432460 |
| Cholestasis | 14.70 | 10.62 | 4 | 56552 | 29430 | 63403036 |
| Pulmonary infarction | 14.65 | 10.62 | 15 | 56541 | 2732 | 63429734 |
| Lactic acidosis | 14.51 | 10.62 | 8 | 56548 | 38279 | 63394187 |
| Drug-induced liver injury | 14.40 | 10.62 | 9 | 56547 | 40213 | 63392253 |
| Extradural haematoma | 14.22 | 10.62 | 12 | 56544 | 1710 | 63430756 |
| Nervousness | 14.21 | 10.62 | 60 | 56496 | 30919 | 63401547 |
| Hyperlipidaemia | 14.17 | 10.62 | 44 | 56512 | 19527 | 63412939 |
| Neuralgia | 14.13 | 10.62 | 53 | 56503 | 25873 | 63406593 |
| Osteonecrosis | 14.09 | 10.62 | 51 | 56505 | 24479 | 63407987 |
| Vestibular disorder | 13.98 | 10.62 | 11 | 56545 | 1420 | 63431046 |
| Pain | 13.93 | 10.62 | 799 | 55757 | 739829 | 62692637 |
| Accidental poisoning | 13.84 | 10.62 | 8 | 56548 | 620 | 63431846 |
| Drug interaction | 13.76 | 10.62 | 134 | 56422 | 228997 | 63203469 |
| Chronic kidney disease | 13.69 | 10.62 | 78 | 56478 | 45320 | 63387146 |
| Therapeutic product effect incomplete | 13.69 | 10.62 | 61 | 56495 | 124995 | 63307471 |
| Erythema | 13.64 | 10.62 | 96 | 56460 | 175655 | 63256811 |
| Major depression | 13.47 | 10.62 | 25 | 56531 | 7993 | 63424473 |
| Product complaint | 13.46 | 10.62 | 33 | 56523 | 12776 | 63419690 |
| Rotator cuff syndrome | 13.36 | 10.62 | 34 | 56522 | 13468 | 63418998 |
| Blood pressure fluctuation | 13.25 | 10.62 | 13 | 56543 | 46304 | 63386162 |
| Road traffic accident | 13.13 | 10.62 | 66 | 56490 | 36566 | 63395900 |
| Crying | 12.95 | 10.62 | 48 | 56508 | 23295 | 63409171 |
| Resorption bone increased | 12.90 | 10.62 | 10 | 56546 | 1264 | 63431202 |
| Muscle tightness | 12.87 | 10.62 | 31 | 56525 | 11869 | 63420597 |
| Septic shock | 12.75 | 10.62 | 25 | 56531 | 66604 | 63365862 |
| Tooth disorder | 12.50 | 10.62 | 54 | 56502 | 28103 | 63404363 |
| Hypoaesthesia | 12.44 | 10.62 | 215 | 56341 | 168178 | 63264288 |
| Spinal osteoarthritis | 12.29 | 10.62 | 37 | 56519 | 16149 | 63416317 |
| Brain oedema | 12.28 | 10.62 | 34 | 56522 | 14161 | 63418305 |
| Intestinal ischaemia | 12.19 | 10.62 | 23 | 56533 | 7445 | 63425021 |
| Unresponsive to stimuli | 12.17 | 10.62 | 61 | 56495 | 33755 | 63398711 |
| Nail growth abnormal | 12.17 | 10.62 | 7 | 56549 | 538 | 63431928 |
| Tendon disorder | 12.13 | 10.62 | 20 | 56536 | 5823 | 63426643 |
| Drug tolerance | 12.09 | 10.62 | 22 | 56534 | 6927 | 63425539 |
| Intervertebral disc disorder | 12.03 | 10.62 | 18 | 56538 | 4825 | 63427641 |
| Transverse sinus thrombosis | 12.01 | 10.62 | 7 | 56549 | 551 | 63431915 |
| Compression fracture | 11.97 | 10.62 | 21 | 56535 | 6427 | 63426039 |
| Nerve injury | 11.95 | 10.62 | 27 | 56529 | 9919 | 63422547 |
| Muscle atrophy | 11.90 | 10.62 | 22 | 56534 | 7011 | 63425455 |
| Blood potassium decreased | 11.89 | 10.62 | 71 | 56485 | 41955 | 63390511 |
| Live birth | 11.87 | 10.62 | 4 | 56552 | 25626 | 63406840 |
| Chronic fatigue syndrome | 11.81 | 10.62 | 9 | 56547 | 1109 | 63431357 |
| Psychological trauma | 11.79 | 10.62 | 9 | 56547 | 1112 | 63431354 |
| Aortic valve incompetence | 11.77 | 10.62 | 20 | 56536 | 5968 | 63426498 |
| Abdominal pain | 11.64 | 10.62 | 343 | 56213 | 293113 | 63139353 |
| Altered state of consciousness | 11.57 | 10.62 | 4 | 56552 | 25226 | 63407240 |
| Prescribed underdose | 11.55 | 10.62 | 6 | 56550 | 29683 | 63402783 |
| Gastrointestinal disorder | 11.55 | 10.62 | 69 | 56487 | 131170 | 63301296 |
| Fat intolerance | 11.50 | 10.62 | 3 | 56553 | 24 | 63432442 |
| Hyponatraemia | 11.41 | 10.62 | 56 | 56500 | 111844 | 63320622 |
| Malabsorption | 11.37 | 10.62 | 16 | 56540 | 4056 | 63428410 |
| Adverse drug reaction | 11.26 | 10.62 | 35 | 56521 | 79679 | 63352787 |
| Constipation | 11.24 | 10.62 | 271 | 56285 | 224672 | 63207794 |
| Brain herniation | 11.10 | 10.62 | 15 | 56541 | 3662 | 63428804 |
| Disease progression | 11.09 | 10.62 | 64 | 56492 | 122694 | 63309772 |
| Angioedema | 11.02 | 10.62 | 16 | 56540 | 47949 | 63384517 |
| Inflammation | 11.01 | 10.62 | 37 | 56519 | 82236 | 63350230 |
| Suicidal ideation | 10.97 | 10.62 | 94 | 56462 | 62327 | 63370139 |
| Screaming | 10.92 | 10.62 | 14 | 56542 | 3248 | 63429218 |
| Mitral valve prolapse | 10.87 | 10.62 | 12 | 56544 | 2381 | 63430085 |
| Electrocardiogram QT prolonged | 10.82 | 10.62 | 23 | 56533 | 59507 | 63372959 |
| COVID-19 | 10.74 | 10.62 | 58 | 56498 | 113045 | 63319421 |
| Hyperkalaemia | 10.66 | 10.62 | 20 | 56536 | 54183 | 63378283 |
| Arteriosclerosis | 10.65 | 10.62 | 26 | 56530 | 10040 | 63422426 |
| Postinfarction angina | 10.65 | 10.62 | 3 | 56553 | 33 | 63432433 |
| Mitral valve incompetence | 10.63 | 10.62 | 40 | 56516 | 19554 | 63412912 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Completed suicide | 509.70 | 12.10 | 532 | 31277 | 97636 | 34827486 |
| Toxicity to various agents | 294.99 | 12.10 | 596 | 31213 | 199766 | 34725356 |
| Accidental overdose | 225.13 | 12.10 | 169 | 31640 | 19971 | 34905151 |
| Drug abuse | 195.78 | 12.10 | 335 | 31474 | 98761 | 34826361 |
| Cardio-respiratory arrest | 189.06 | 12.10 | 242 | 31567 | 55031 | 34870091 |
| Drug dependence | 161.91 | 12.10 | 151 | 31658 | 24066 | 34901056 |
| Respiratory arrest | 139.68 | 12.10 | 149 | 31660 | 27894 | 34897228 |
| Drug abuser | 115.31 | 12.10 | 61 | 31748 | 3893 | 34921229 |
| Off label use | 106.34 | 12.10 | 136 | 31673 | 419388 | 34505734 |
| Overdose | 103.88 | 12.10 | 245 | 31564 | 90814 | 34834308 |
| Drug withdrawal syndrome | 92.82 | 12.10 | 102 | 31707 | 19732 | 34905390 |
| Intentional product misuse | 70.66 | 12.10 | 139 | 31670 | 45472 | 34879650 |
| Depression | 69.33 | 12.10 | 220 | 31589 | 96878 | 34828244 |
| Anxiety | 67.12 | 12.10 | 221 | 31588 | 99207 | 34825915 |
| Inadequate analgesia | 62.48 | 12.10 | 37 | 31772 | 2938 | 34922184 |
| Emotional distress | 58.04 | 12.10 | 70 | 31739 | 14956 | 34910166 |
| Cardiac arrest | 52.21 | 12.10 | 199 | 31610 | 95960 | 34829162 |
| Respiratory depression | 47.58 | 12.10 | 66 | 31743 | 16179 | 34908943 |
| Gun shot wound | 46.46 | 12.10 | 22 | 31787 | 1106 | 34924016 |
| Drug hypersensitivity | 44.81 | 12.10 | 168 | 31641 | 80361 | 34844761 |
| Insomnia | 43.81 | 12.10 | 199 | 31610 | 103708 | 34821414 |
| Coronary artery disease | 38.68 | 12.10 | 114 | 31695 | 48191 | 34876931 |
| Pyrexia | 38.03 | 12.10 | 165 | 31644 | 332848 | 34592274 |
| C-reactive protein increased | 37.87 | 12.10 | 3 | 31806 | 54095 | 34871027 |
| Death | 36.36 | 12.10 | 535 | 31274 | 397514 | 34527608 |
| General physical health deterioration | 36.17 | 12.10 | 38 | 31771 | 128231 | 34796891 |
| Myocardial infarction | 35.14 | 12.10 | 209 | 31600 | 120876 | 34804246 |
| Ventricular hypertrophy | 33.24 | 12.10 | 30 | 31779 | 4577 | 34920545 |
| Drug screen positive | 33.13 | 12.10 | 28 | 31781 | 3915 | 34921207 |
| Accidental death | 32.86 | 12.10 | 23 | 31786 | 2433 | 34922689 |
| Pain | 32.41 | 12.10 | 306 | 31503 | 204369 | 34720753 |
| Chest pain | 31.92 | 12.10 | 211 | 31598 | 126551 | 34798571 |
| Product use in unapproved indication | 30.73 | 12.10 | 37 | 31772 | 117462 | 34807660 |
| Drug tolerance | 29.57 | 12.10 | 23 | 31786 | 2859 | 34922263 |
| Drug interaction | 29.53 | 12.10 | 106 | 31703 | 225840 | 34699282 |
| Back pain | 29.03 | 12.10 | 200 | 31609 | 121589 | 34803533 |
| Substance abuse | 28.53 | 12.10 | 35 | 31774 | 7606 | 34917516 |
| Lumbar radiculopathy | 27.41 | 12.10 | 14 | 31795 | 830 | 34924292 |
| Laryngospasm | 27.03 | 12.10 | 17 | 31792 | 1504 | 34923618 |
| COVID-19 | 26.68 | 12.10 | 19 | 31790 | 77531 | 34847591 |
| Dependence | 25.99 | 12.10 | 15 | 31794 | 1135 | 34923987 |
| Arteriosclerosis | 25.60 | 12.10 | 42 | 31767 | 11926 | 34913196 |
| Intervertebral disc protrusion | 25.56 | 12.10 | 38 | 31771 | 9918 | 34915204 |
| Hypoaesthesia | 25.36 | 12.10 | 117 | 31692 | 61327 | 34863795 |
| Condition aggravated | 25.21 | 12.10 | 90 | 31719 | 192106 | 34733016 |
| Intervertebral disc degeneration | 24.95 | 12.10 | 30 | 31779 | 6387 | 34918735 |
| Hepatic function abnormal | 24.95 | 12.10 | 5 | 31804 | 44358 | 34880764 |
| Cardiac failure | 23.57 | 12.10 | 29 | 31780 | 91219 | 34833903 |
| Pain in extremity | 23.52 | 12.10 | 196 | 31613 | 126317 | 34798805 |
| Renal impairment | 23.42 | 12.10 | 31 | 31778 | 94482 | 34830640 |
| Neutropenia | 22.91 | 12.10 | 70 | 31739 | 156708 | 34768414 |
| Spinal osteoarthritis | 22.17 | 12.10 | 31 | 31778 | 7652 | 34917470 |
| Interstitial lung disease | 21.16 | 12.10 | 17 | 31792 | 65265 | 34859857 |
| Acute kidney injury | 21.08 | 12.10 | 177 | 31632 | 304811 | 34620311 |
| Back injury | 21.04 | 12.10 | 22 | 31787 | 4019 | 34921103 |
| Febrile neutropenia | 20.78 | 12.10 | 60 | 31749 | 136789 | 34788333 |
| Pulmonary congestion | 20.16 | 12.10 | 41 | 31768 | 13724 | 34911398 |
| Mental status changes | 19.97 | 12.10 | 78 | 31731 | 38005 | 34887117 |
| Carpal tunnel syndrome | 19.87 | 12.10 | 23 | 31786 | 4703 | 34920419 |
| Poisoning | 19.82 | 12.10 | 38 | 31771 | 12188 | 34912934 |
| Environmental exposure | 19.51 | 12.10 | 8 | 31801 | 284 | 34924838 |
| Arteriosclerosis coronary artery | 19.25 | 12.10 | 38 | 31771 | 12447 | 34912675 |
| Antasthmatic drug level | 19.07 | 12.10 | 5 | 31804 | 40 | 34925082 |
| Hypoxic-ischaemic encephalopathy | 18.96 | 12.10 | 22 | 31787 | 4510 | 34920612 |
| Road traffic accident | 18.82 | 12.10 | 46 | 31763 | 17404 | 34907718 |
| Analgesic drug level | 18.75 | 12.10 | 5 | 31804 | 43 | 34925079 |
| Leukopenia | 18.41 | 12.10 | 18 | 31791 | 62838 | 34862284 |
| Foetal exposure during pregnancy | 18.16 | 12.10 | 6 | 31803 | 38095 | 34887027 |
| Rotator cuff syndrome | 18.13 | 12.10 | 24 | 31785 | 5625 | 34919497 |
| Nervousness | 17.81 | 12.10 | 37 | 31772 | 12569 | 34912553 |
| Gastrooesophageal reflux disease | 17.76 | 12.10 | 75 | 31734 | 37849 | 34887273 |
| Cardiomegaly | 16.98 | 12.10 | 41 | 31768 | 15397 | 34909725 |
| Plasma cell myeloma | 16.57 | 12.10 | 79 | 31730 | 41958 | 34883164 |
| Back disorder | 16.52 | 12.10 | 25 | 31784 | 6626 | 34918496 |
| Pulmonary oedema | 16.39 | 12.10 | 86 | 31723 | 47443 | 34877679 |
| Postictal state | 16.19 | 12.10 | 10 | 31799 | 857 | 34924265 |
| Walking disability | 15.61 | 12.10 | 10 | 31799 | 913 | 34924209 |
| Hyperlipidaemia | 15.35 | 12.10 | 38 | 31771 | 14491 | 34910631 |
| Burning sensation | 15.28 | 12.10 | 44 | 31765 | 18350 | 34906772 |
| Reaction to excipient | 15.17 | 12.10 | 8 | 31801 | 507 | 34924615 |
| Drug-induced liver injury | 14.72 | 12.10 | 4 | 31805 | 28828 | 34896294 |
| Mitral valve incompetence | 14.66 | 12.10 | 38 | 31771 | 14905 | 34910217 |
| Anger | 14.64 | 12.10 | 33 | 31776 | 11851 | 34913271 |
| Coronary artery stenosis | 14.51 | 12.10 | 29 | 31780 | 9587 | 34915535 |
| Complex regional pain syndrome | 14.45 | 12.10 | 8 | 31801 | 559 | 34924563 |
| Liver disorder | 14.37 | 12.10 | 6 | 31803 | 32991 | 34892131 |
| Blood cholesterol increased | 14.13 | 12.10 | 46 | 31763 | 20497 | 34904625 |
| Thymus disorder | 14.12 | 12.10 | 3 | 31806 | 8 | 34925114 |
| Irritability | 14.12 | 12.10 | 52 | 31757 | 24638 | 34900484 |
| Thrombocytopenia | 14.03 | 12.10 | 84 | 31725 | 156163 | 34768959 |
| Injury | 13.94 | 12.10 | 46 | 31763 | 20641 | 34904481 |
| Osteomyelitis | 13.79 | 12.10 | 39 | 31770 | 16097 | 34909025 |
| Lower respiratory tract infection | 13.39 | 12.10 | 6 | 31803 | 31631 | 34893491 |
| Phantom limb syndrome | 13.38 | 12.10 | 6 | 31803 | 266 | 34924856 |
| Bronchitis | 13.17 | 12.10 | 74 | 31735 | 41889 | 34883233 |
| Treatment failure | 12.96 | 12.10 | 14 | 31795 | 46683 | 34878439 |
| Groin pain | 12.68 | 12.10 | 20 | 31789 | 5493 | 34919629 |
| Dental caries | 12.63 | 12.10 | 18 | 31791 | 4521 | 34920601 |
| Peripheral vascular disorder | 12.61 | 12.10 | 19 | 31790 | 5017 | 34920105 |
| Decreased interest | 12.56 | 12.10 | 13 | 31796 | 2347 | 34922775 |
| Radiculopathy | 12.48 | 12.10 | 14 | 31795 | 2767 | 34922355 |
| Neutrophil count decreased | 12.41 | 12.10 | 17 | 31792 | 51087 | 34874035 |
| Seizure like phenomena | 12.24 | 12.10 | 8 | 31801 | 756 | 34924366 |
| Haemorrhoids | 12.23 | 12.10 | 35 | 31774 | 14540 | 34910582 |
| Drug use disorder | 12.23 | 12.10 | 17 | 31792 | 4174 | 34920948 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Completed suicide | 1718.07 | 10.87 | 1512 | 65466 | 244255 | 79433155 |
| Toxicity to various agents | 729.43 | 10.87 | 1283 | 65695 | 420257 | 79257153 |
| Cardio-respiratory arrest | 553.15 | 10.87 | 562 | 66416 | 107948 | 79569462 |
| Cholecystitis chronic | 425.52 | 10.87 | 194 | 66784 | 9712 | 79667698 |
| Drug abuse | 385.03 | 10.87 | 572 | 66406 | 162119 | 79515291 |
| Respiratory arrest | 343.24 | 10.87 | 325 | 66653 | 57225 | 79620185 |
| Accidental overdose | 266.01 | 10.87 | 239 | 66739 | 39342 | 79638068 |
| Emotional distress | 240.72 | 10.87 | 227 | 66751 | 39742 | 79637668 |
| Intentional product misuse | 205.65 | 10.87 | 321 | 66657 | 94844 | 79582566 |
| Drug hypersensitivity | 189.85 | 10.87 | 617 | 66361 | 298299 | 79379111 |
| Anxiety | 181.89 | 10.87 | 539 | 66439 | 247973 | 79429437 |
| Off label use | 179.29 | 10.87 | 305 | 66673 | 906910 | 78770500 |
| Injury | 164.07 | 10.87 | 259 | 66719 | 77237 | 79600173 |
| Gallbladder disorder | 158.80 | 10.87 | 131 | 66847 | 19209 | 79658201 |
| Cardiac arrest | 156.29 | 10.87 | 404 | 66574 | 171692 | 79505718 |
| Death | 153.38 | 10.87 | 904 | 66074 | 565610 | 79111800 |
| Depression | 151.78 | 10.87 | 463 | 66515 | 216327 | 79461083 |
| Drug abuser | 148.87 | 10.87 | 81 | 66897 | 5932 | 79671478 |
| Cholelithiasis | 143.17 | 10.87 | 198 | 66780 | 52466 | 79624944 |
| Overdose | 142.82 | 10.87 | 408 | 66570 | 183798 | 79493612 |
| Drug dependence | 131.99 | 10.87 | 167 | 66811 | 40602 | 79636808 |
| Contraindicated product administered | 107.88 | 10.87 | 6 | 66972 | 157532 | 79519878 |
| Drug withdrawal syndrome | 107.32 | 10.87 | 139 | 66839 | 34579 | 79642831 |
| Deep vein thrombosis | 103.73 | 10.87 | 278 | 66700 | 120641 | 79556769 |
| Biliary dyskinesia | 100.41 | 10.87 | 47 | 66931 | 2498 | 79674912 |
| Synovitis | 99.44 | 10.87 | 7 | 66971 | 150727 | 79526683 |
| Accidental death | 98.51 | 10.87 | 55 | 66923 | 4236 | 79673174 |
| Maternal exposure during pregnancy | 94.11 | 10.87 | 5 | 66973 | 136533 | 79540877 |
| Infusion related reaction | 93.73 | 10.87 | 38 | 66940 | 230199 | 79447211 |
| Drug intolerance | 93.17 | 10.87 | 53 | 66925 | 264066 | 79413344 |
| Coronary artery disease | 92.14 | 10.87 | 183 | 66795 | 65291 | 79612119 |
| Inadequate analgesia | 84.18 | 10.87 | 51 | 66927 | 4578 | 79672832 |
| Gallbladder injury | 82.59 | 10.87 | 33 | 66945 | 1188 | 79676222 |
| C-reactive protein increased | 79.60 | 10.87 | 8 | 66970 | 129019 | 79548391 |
| Respiratory depression | 78.27 | 10.87 | 106 | 66872 | 27524 | 79649886 |
| Pyrexia | 74.20 | 10.87 | 306 | 66672 | 678403 | 78999007 |
| Treatment failure | 71.25 | 10.87 | 27 | 66951 | 170459 | 79506951 |
| Hand deformity | 71.00 | 10.87 | 4 | 66974 | 103915 | 79573495 |
| Lower respiratory tract infection | 70.18 | 10.87 | 12 | 66966 | 129208 | 79548202 |
| Drug ineffective | 62.63 | 10.87 | 594 | 66384 | 1080319 | 78597091 |
| Joint swelling | 55.83 | 10.87 | 98 | 66880 | 288548 | 79388862 |
| Pericarditis | 53.78 | 10.87 | 11 | 66967 | 104225 | 79573185 |
| Systemic lupus erythematosus | 52.63 | 10.87 | 18 | 66960 | 121131 | 79556279 |
| Neutropenia | 51.82 | 10.87 | 102 | 66876 | 287608 | 79389802 |
| Chest pain | 49.68 | 10.87 | 406 | 66572 | 281898 | 79395512 |
| Insomnia | 49.47 | 10.87 | 364 | 66614 | 244806 | 79432604 |
| Glossodynia | 49.15 | 10.87 | 13 | 66965 | 103324 | 79574086 |
| Febrile neutropenia | 48.80 | 10.87 | 74 | 66904 | 230925 | 79446485 |
| Poisoning | 48.73 | 10.87 | 81 | 66897 | 25191 | 79652219 |
| Myocardial infarction | 47.75 | 10.87 | 291 | 66687 | 183838 | 79493572 |
| Mental status changes | 47.69 | 10.87 | 144 | 66834 | 66815 | 79610595 |
| Pulmonary embolism | 47.53 | 10.87 | 276 | 66702 | 171378 | 79506032 |
| Product use in unapproved indication | 47.50 | 10.87 | 86 | 66892 | 250273 | 79427137 |
| Back pain | 47.00 | 10.87 | 425 | 66553 | 303755 | 79373655 |
| Gallbladder hypofunction | 44.85 | 10.87 | 17 | 66961 | 530 | 79676880 |
| Gun shot wound | 44.29 | 10.87 | 21 | 66957 | 1149 | 79676261 |
| Condition aggravated | 43.55 | 10.87 | 245 | 66733 | 500879 | 79176531 |
| Drug screen positive | 43.48 | 10.87 | 38 | 66940 | 6025 | 79671385 |
| Cardiac failure | 42.95 | 10.87 | 40 | 66938 | 154802 | 79522608 |
| Cerebrovascular accident | 42.54 | 10.87 | 249 | 66729 | 155043 | 79522367 |
| Rash | 41.44 | 10.87 | 300 | 66678 | 578058 | 79099352 |
| Helicobacter infection | 41.27 | 10.87 | 5 | 66973 | 69699 | 79607711 |
| Renal impairment | 40.07 | 10.87 | 44 | 66934 | 157739 | 79519671 |
| Hypersensitivity | 39.84 | 10.87 | 102 | 66876 | 262137 | 79415273 |
| Interstitial lung disease | 39.09 | 10.87 | 23 | 66955 | 112577 | 79564833 |
| Exposure during pregnancy | 39.05 | 10.87 | 18 | 66960 | 101114 | 79576296 |
| Nasopharyngitis | 37.61 | 10.87 | 100 | 66878 | 253781 | 79423629 |
| Pain | 37.28 | 10.87 | 812 | 66166 | 702990 | 78974420 |
| Pain in extremity | 36.95 | 10.87 | 468 | 66510 | 364070 | 79313340 |
| Intervertebral disc protrusion | 36.86 | 10.87 | 69 | 66909 | 23552 | 79653858 |
| Scar | 36.67 | 10.87 | 54 | 66924 | 15142 | 79662268 |
| Product use issue | 36.39 | 10.87 | 76 | 66902 | 209746 | 79467664 |
| Rheumatoid factor positive | 36.15 | 10.87 | 4 | 66974 | 59835 | 79617575 |
| Drug interaction | 35.50 | 10.87 | 204 | 66774 | 414979 | 79262431 |
| Drug tolerance | 35.41 | 10.87 | 40 | 66938 | 8635 | 79668775 |
| Hepatic enzyme increased | 35.28 | 10.87 | 62 | 66916 | 182548 | 79494862 |
| COVID-19 | 34.77 | 10.87 | 49 | 66929 | 157625 | 79519785 |
| Anhedonia | 34.60 | 10.87 | 52 | 66926 | 14846 | 79662564 |
| Thrombocytopenia | 33.86 | 10.87 | 112 | 66866 | 265147 | 79412263 |
| Ventricular hypertrophy | 33.58 | 10.87 | 35 | 66943 | 6903 | 79670507 |
| Hepatic function abnormal | 33.27 | 10.87 | 10 | 66968 | 73097 | 79604313 |
| General physical health deterioration | 33.25 | 10.87 | 119 | 66859 | 275119 | 79402291 |
| Biliary colic | 32.86 | 10.87 | 27 | 66951 | 3935 | 79673475 |
| Cholestasis | 32.74 | 10.87 | 3 | 66975 | 52106 | 79625304 |
| Leukopenia | 32.42 | 10.87 | 30 | 66948 | 116483 | 79560927 |
| Gamma-glutamyltransferase increased | 32.18 | 10.87 | 4 | 66974 | 54676 | 79622734 |
| Liver injury | 31.30 | 10.87 | 5 | 66973 | 56609 | 79620801 |
| Back injury | 30.76 | 10.87 | 41 | 66937 | 10482 | 79666928 |
| Drug reaction with eosinophilia and systemic symptoms | 30.71 | 10.87 | 8 | 66970 | 64236 | 79613174 |
| Arteriosclerosis | 30.66 | 10.87 | 55 | 66923 | 18172 | 79659238 |
| Dependence | 30.06 | 10.87 | 21 | 66957 | 2401 | 79675009 |
| Wound | 29.93 | 10.87 | 32 | 66946 | 116147 | 79561263 |
| Substance abuse | 29.23 | 10.87 | 40 | 66938 | 10486 | 79666924 |
| Gallbladder cholesterolosis | 28.84 | 10.87 | 13 | 66965 | 633 | 79676777 |
| Discomfort | 28.74 | 10.87 | 38 | 66940 | 125579 | 79551831 |
| Hyperlipidaemia | 28.69 | 10.87 | 66 | 66912 | 26027 | 79651383 |
| Feeling abnormal | 28.53 | 10.87 | 230 | 66748 | 158969 | 79518441 |
| Cholesterosis | 28.37 | 10.87 | 11 | 66967 | 365 | 79677045 |
| Folliculitis | 28.24 | 10.87 | 6 | 66972 | 55374 | 79622036 |
| Muscle injury | 27.51 | 10.87 | 4 | 66974 | 48557 | 79628853 |
| Eosinophilia | 27.47 | 10.87 | 3 | 66975 | 45342 | 79632068 |
| Uterine perforation | 27.34 | 10.87 | 30 | 66948 | 6273 | 79671137 |
| Gastrooesophageal reflux disease | 27.16 | 10.87 | 165 | 66813 | 104081 | 79573329 |
| Toxic epidermal necrolysis | 26.88 | 10.87 | 3 | 66975 | 44578 | 79632832 |
| Nervousness | 26.80 | 10.87 | 75 | 66903 | 33340 | 79644070 |
| Inflammation | 26.25 | 10.87 | 24 | 66954 | 93729 | 79583681 |
| Erythema | 26.00 | 10.87 | 98 | 66880 | 223192 | 79454218 |
| Road traffic accident | 25.72 | 10.87 | 88 | 66890 | 43576 | 79633834 |
| Rotator cuff syndrome | 25.61 | 10.87 | 44 | 66934 | 14051 | 79663359 |
| Muscle spasms | 25.36 | 10.87 | 241 | 66737 | 174489 | 79502921 |
| Cholecystitis | 25.33 | 10.87 | 57 | 66921 | 22155 | 79655255 |
| Drug-induced liver injury | 25.16 | 10.87 | 12 | 66966 | 66105 | 79611305 |
| Cholecystectomy | 24.93 | 10.87 | 35 | 66943 | 9397 | 79668013 |
| Hyponatraemia | 24.88 | 10.87 | 72 | 66906 | 177776 | 79499634 |
| Peripheral vascular disorder | 24.57 | 10.87 | 32 | 66946 | 7998 | 79669412 |
| Liver disorder | 23.47 | 10.87 | 16 | 66962 | 72401 | 79605009 |
| Infection | 23.29 | 10.87 | 114 | 66864 | 241598 | 79435812 |
| Intervertebral disc degeneration | 23.26 | 10.87 | 45 | 66933 | 15740 | 79661670 |
| Rash maculo-papular | 23.22 | 10.87 | 9 | 66969 | 56069 | 79621341 |
| Arteriosclerosis coronary artery | 22.92 | 10.87 | 48 | 66930 | 17768 | 79659642 |
| Blood pressure systolic increased | 22.80 | 10.87 | 14 | 66964 | 66972 | 79610438 |
| Coronary artery stenosis | 22.72 | 10.87 | 39 | 66939 | 12445 | 79664965 |
| Rheumatoid arthritis | 22.67 | 10.87 | 94 | 66884 | 208376 | 79469034 |
| Acute kidney injury | 22.58 | 10.87 | 304 | 66674 | 519100 | 79158310 |
| Therapeutic product effect decreased | 22.44 | 10.87 | 67 | 66911 | 163796 | 79513614 |
| Stomatitis | 22.33 | 10.87 | 57 | 66921 | 146700 | 79530710 |
| Sleep disorder due to general medical condition, insomnia type | 21.64 | 10.87 | 5 | 66973 | 43551 | 79633859 |
| Coagulopathy | 21.59 | 10.87 | 73 | 66905 | 35933 | 79641477 |
| Tarsal tunnel syndrome | 21.46 | 10.87 | 10 | 66968 | 526 | 79676884 |
| Acute lung injury | 21.37 | 10.87 | 19 | 66959 | 3081 | 79674329 |
| Spinal osteoarthritis | 21.07 | 10.87 | 45 | 66933 | 16882 | 79660528 |
| Mental disorder | 21.05 | 10.87 | 66 | 66912 | 31236 | 79646174 |
| Pulmonary congestion | 20.93 | 10.87 | 60 | 66918 | 27040 | 79650370 |
| Drug resistance | 20.67 | 10.87 | 5 | 66973 | 42208 | 79635202 |
| Blood pressure fluctuation | 20.25 | 10.87 | 16 | 66962 | 67129 | 79610281 |
| Mitral valve incompetence | 19.93 | 10.87 | 61 | 66917 | 28504 | 79648906 |
| Memory impairment | 19.78 | 10.87 | 161 | 66817 | 111573 | 79565837 |
| Hypoaesthesia | 19.75 | 10.87 | 234 | 66744 | 179118 | 79498292 |
| Lactic acidosis | 19.71 | 10.87 | 18 | 66960 | 70341 | 79607069 |
| Back disorder | 19.55 | 10.87 | 35 | 66943 | 11543 | 79665867 |
| Lumbar radiculopathy | 19.53 | 10.87 | 15 | 66963 | 1984 | 79675426 |
| Angina unstable | 19.51 | 10.87 | 43 | 66935 | 16484 | 79660926 |
| Antasthmatic drug level | 19.46 | 10.87 | 5 | 66973 | 40 | 79677370 |
| Thrombosis | 19.35 | 10.87 | 129 | 66849 | 83971 | 79593439 |
| Hyperkalaemia | 19.35 | 10.87 | 42 | 66936 | 114356 | 79563054 |
| Septic shock | 19.23 | 10.87 | 47 | 66931 | 122754 | 79554656 |
| Hepatocellular injury | 19.11 | 10.87 | 8 | 66970 | 47585 | 79629825 |
| Chronic obstructive pulmonary disease | 19.05 | 10.87 | 130 | 66848 | 85289 | 79592121 |
| Analgesic drug level | 18.94 | 10.87 | 5 | 66973 | 45 | 79677365 |
| Emotional disorder | 18.79 | 10.87 | 39 | 66939 | 14348 | 79663062 |
| Purpura senile | 18.51 | 10.87 | 9 | 66969 | 521 | 79676889 |
| Altered state of consciousness | 18.20 | 10.87 | 7 | 66971 | 43815 | 79633595 |
| Cardiomegaly | 18.13 | 10.87 | 56 | 66922 | 26296 | 79651114 |
| Multiple organ dysfunction syndrome | 18.07 | 10.87 | 47 | 66931 | 120199 | 79557211 |
| Epilepsy | 17.86 | 10.87 | 6 | 66972 | 40854 | 79636556 |
| Pneumocystis jirovecii pneumonia | 17.68 | 10.87 | 3 | 66975 | 32505 | 79644905 |
| Environmental exposure | 17.66 | 10.87 | 8 | 66970 | 394 | 79677016 |
| Chronic fatigue syndrome | 17.47 | 10.87 | 12 | 66966 | 1335 | 79676075 |
| Fear | 17.29 | 10.87 | 49 | 66929 | 21937 | 79655473 |
| Neutrophil count decreased | 17.16 | 10.87 | 33 | 66945 | 93926 | 79583484 |
| Bone marrow failure | 16.96 | 10.87 | 11 | 66967 | 51096 | 79626314 |
| Obstructive airways disorder | 16.90 | 10.87 | 3 | 66975 | 31456 | 79645954 |
| Pancytopenia | 16.64 | 10.87 | 77 | 66901 | 165668 | 79511742 |
| Major depression | 16.27 | 10.87 | 28 | 66950 | 8952 | 79668458 |
| Irritability | 16.16 | 10.87 | 73 | 66905 | 41071 | 79636339 |
| Migraine | 15.99 | 10.87 | 127 | 66851 | 87366 | 79590044 |
| Intervertebral disc disorder | 15.98 | 10.87 | 20 | 66958 | 4805 | 79672605 |
| Carpal tunnel syndrome | 15.83 | 10.87 | 44 | 66934 | 19484 | 79657926 |
| Multiple injuries | 15.80 | 10.87 | 17 | 66961 | 3478 | 79673932 |
| Withdrawal syndrome | 15.71 | 10.87 | 54 | 66924 | 26800 | 79650610 |
| Melaena | 15.43 | 10.87 | 17 | 66961 | 60873 | 79616537 |
| Suspected suicide | 15.40 | 10.87 | 30 | 66948 | 10546 | 79666864 |
| Neck injury | 15.23 | 10.87 | 15 | 66963 | 2766 | 79674644 |
| Red blood cell sedimentation rate increased | 15.09 | 10.87 | 10 | 66968 | 45932 | 79631478 |
| Wheezing | 15.05 | 10.87 | 49 | 66929 | 116615 | 79560795 |
| Musculoskeletal stiffness | 14.92 | 10.87 | 86 | 66892 | 174922 | 79502488 |
| Peptic ulcer | 14.85 | 10.87 | 22 | 66956 | 6201 | 79671209 |
| Extradural haematoma | 14.81 | 10.87 | 15 | 66963 | 2861 | 79674549 |
| Transaminases increased | 14.78 | 10.87 | 13 | 66965 | 51730 | 79625680 |
| Arthropathy | 14.59 | 10.87 | 88 | 66890 | 177023 | 79500387 |
| Anaphylactic shock | 14.54 | 10.87 | 6 | 66972 | 35990 | 79641420 |
| Postinfarction angina | 14.51 | 10.87 | 4 | 66974 | 43 | 79677367 |
| Angioedema | 14.51 | 10.87 | 26 | 66952 | 76009 | 79601401 |
| Pulmonary oedema | 14.46 | 10.87 | 125 | 66853 | 88129 | 79589281 |
| Cardiac failure congestive | 14.46 | 10.87 | 183 | 66795 | 142219 | 79535191 |
| Lymphopenia | 14.23 | 10.87 | 4 | 66974 | 30553 | 79646857 |
| Crying | 14.06 | 10.87 | 47 | 66931 | 22996 | 79654414 |
| Accident | 14.03 | 10.87 | 26 | 66952 | 8805 | 79668605 |
| Laryngospasm | 13.94 | 10.87 | 17 | 66961 | 3980 | 79673430 |
| Cardiogenic shock | 13.93 | 10.87 | 9 | 66969 | 41905 | 79635505 |
| Coronary artery occlusion | 13.92 | 10.87 | 36 | 66942 | 15279 | 79662131 |
| Drug eruption | 13.85 | 10.87 | 10 | 66968 | 43925 | 79633485 |
| Nausea | 13.72 | 10.87 | 956 | 66022 | 956240 | 78721170 |
| Psoriatic arthropathy | 13.72 | 10.87 | 28 | 66950 | 77971 | 79599439 |
| Head injury | 13.72 | 10.87 | 65 | 66913 | 37304 | 79640106 |
| Unresponsive to stimuli | 13.71 | 10.87 | 87 | 66891 | 55701 | 79621709 |
| Hypoxic-ischaemic encephalopathy | 13.67 | 10.87 | 24 | 66954 | 7796 | 79669614 |
| Copper deficiency | 13.66 | 10.87 | 5 | 66973 | 141 | 79677269 |
| Acute myocardial infarction | 13.63 | 10.87 | 111 | 66867 | 76925 | 79600485 |
| Prescribed underdose | 13.50 | 10.87 | 4 | 66974 | 29510 | 79647900 |
| Urticaria | 13.25 | 10.87 | 96 | 66882 | 185105 | 79492305 |
| Brain oedema | 13.24 | 10.87 | 49 | 66929 | 25214 | 79652196 |
| Opiates positive | 13.15 | 10.87 | 9 | 66969 | 995 | 79676415 |
| Anaphylactic reaction | 13.15 | 10.87 | 32 | 66946 | 83711 | 79593699 |
| Respiratory disorder | 13.14 | 10.87 | 11 | 66967 | 44845 | 79632565 |
| Musculoskeletal chest pain | 12.95 | 10.87 | 48 | 66930 | 24716 | 79652694 |
| Respiratory muscle weakness | 12.89 | 10.87 | 6 | 66972 | 315 | 79677095 |
| Neuropathy peripheral | 12.86 | 10.87 | 178 | 66800 | 141127 | 79536283 |
| Pulmonary infarction | 12.82 | 10.87 | 16 | 66962 | 3833 | 79673577 |
| Tooth loss | 12.74 | 10.87 | 22 | 66956 | 7053 | 79670357 |
| Pallor | 12.66 | 10.87 | 14 | 66964 | 50048 | 79627362 |
| Cholecystitis acute | 12.62 | 10.87 | 32 | 66946 | 13419 | 79663991 |
| Hepatitis | 12.60 | 10.87 | 17 | 66961 | 55710 | 79621700 |
| Heart rate decreased | 12.58 | 10.87 | 25 | 66953 | 70291 | 79607119 |
| Hernia | 12.43 | 10.87 | 37 | 66941 | 17022 | 79660388 |
| Laryngeal pain | 12.33 | 10.87 | 20 | 66958 | 6094 | 79671316 |
| Malabsorption | 12.31 | 10.87 | 18 | 66960 | 5014 | 79672396 |
| Anger | 12.30 | 10.87 | 37 | 66941 | 17125 | 79660285 |
| Restless legs syndrome | 12.28 | 10.87 | 41 | 66937 | 20051 | 79657359 |
| Blood pressure diastolic decreased | 12.26 | 10.87 | 5 | 66973 | 30211 | 79647199 |
| Transient ischaemic attack | 12.23 | 10.87 | 81 | 66897 | 52614 | 79624796 |
| Resorption bone increased | 12.12 | 10.87 | 10 | 66968 | 1465 | 79675945 |
| Phantom limb syndrome | 12.11 | 10.87 | 6 | 66972 | 362 | 79677048 |
| Toxic leukoencephalopathy | 12.03 | 10.87 | 9 | 66969 | 1145 | 79676265 |
| Dehydration | 12.02 | 10.87 | 283 | 66695 | 247904 | 79429506 |
| Eczema | 11.97 | 10.87 | 10 | 66968 | 40808 | 79636602 |
| Post concussion syndrome | 11.94 | 10.87 | 7 | 66971 | 591 | 79676819 |
| Muscle atrophy | 11.90 | 10.87 | 28 | 66950 | 11204 | 79666206 |
| Product complaint | 11.74 | 10.87 | 31 | 66947 | 13318 | 79664092 |
| Alopecia | 11.70 | 10.87 | 131 | 66847 | 231224 | 79446186 |
| Snake bite | 11.68 | 10.87 | 3 | 66975 | 24 | 79677386 |
| Peripheral swelling | 11.62 | 10.87 | 158 | 66820 | 269459 | 79407951 |
| Platelet count decreased | 11.59 | 10.87 | 106 | 66872 | 194558 | 79482852 |
| Therapeutic product effect increased | 11.57 | 10.87 | 10 | 66968 | 1561 | 79675849 |
| Polyneuropathy | 11.55 | 10.87 | 3 | 66975 | 24148 | 79653262 |
| Chronic kidney disease | 11.53 | 10.87 | 95 | 66883 | 66059 | 79611351 |
| Colitis | 11.52 | 10.87 | 28 | 66950 | 73279 | 79604131 |
| Transverse sinus thrombosis | 11.26 | 10.87 | 7 | 66971 | 658 | 79676752 |
| Amnesia | 11.23 | 10.87 | 91 | 66887 | 62966 | 79614444 |
| Osteomyelitis | 11.22 | 10.87 | 56 | 66922 | 32809 | 79644601 |
| Tendon disorder | 11.22 | 10.87 | 21 | 66957 | 7165 | 79670245 |
| Oxygen saturation decreased | 11.22 | 10.87 | 63 | 66915 | 128984 | 79548426 |
| Sepsis | 11.21 | 10.87 | 159 | 66819 | 269269 | 79408141 |
| Inappropriate schedule of product administration | 11.21 | 10.87 | 66 | 66912 | 133562 | 79543848 |
| Myofascial pain syndrome | 11.18 | 10.87 | 11 | 66967 | 2026 | 79675384 |
| Complex regional pain syndrome | 11.13 | 10.87 | 11 | 66967 | 2037 | 79675373 |
| Intentional overdose | 11.11 | 10.87 | 137 | 66841 | 105823 | 79571587 |
| Accidental poisoning | 11.11 | 10.87 | 10 | 66968 | 1647 | 79675763 |
| Panic attack | 11.08 | 10.87 | 45 | 66933 | 24171 | 79653239 |
| Stevens-Johnson syndrome | 10.99 | 10.87 | 10 | 66968 | 39156 | 79638254 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | R05DA03 | RESPIRATORY SYSTEM COUGH AND COLD PREPARATIONS COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS Opium alkaloids and derivatives |
| FDA MoA | N0000000174 | Opioid Agonists |
| MeSH PA | D000700 | Analgesics |
| MeSH PA | D000701 | Analgesics, Opioid |
| MeSH PA | D000996 | Antitussive Agents |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D002492 | Central Nervous System Depressants |
| MeSH PA | D009294 | Narcotics |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| MeSH PA | D019141 | Respiratory System Agents |
| MeSH PA | D018689 | Sensory System Agents |
| CHEBI has role | CHEBI:35482 | narcotic analgesic |
| CHEBI has role | CHEBI:51177 | anti-tussive |
| CHEBI has role | CHEBI:55322 | mu-opioid agonists |
| FDA EPC | N0000175690 | Opioid Agonist |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Pain | indication | 22253000 | |
| Cough | indication | 49727002 | |
| Allergic rhinitis | indication | 61582004 | |
| Nasal discharge | indication | 64531003 | |
| Nasal congestion | indication | 68235000 | |
| Rhinitis | indication | 70076002 | DOID:4483 |
| Common cold | indication | 82272006 | DOID:10459 |
| Brain damage | contraindication | 2470005 | |
| Ocular hypertension | contraindication | 4210003 | DOID:9282 |
| Tachyarrhythmia | contraindication | 6285003 | |
| Suicidal thoughts | contraindication | 6471006 | |
| Dependent drug abuse | contraindication | 6525002 | |
| Urinary tract obstruction | contraindication | 7163005 | DOID:5200 |
| Alcoholism | contraindication | 7200002 | |
| Alcohol withdrawal delirium | contraindication | 8635005 | |
| Peptic ulcer | contraindication | 13200003 | DOID:750 |
| Chronic obstructive lung disease | contraindication | 13645005 | DOID:3083 |
| Asthenia | contraindication | 13791008 | |
| Hyperkalemia | contraindication | 14140009 | |
| Severe chronic ulcerative colitis | contraindication | 14311001 | |
| Constipation | contraindication | 14760008 | DOID:2089 |
| Mood swings | contraindication | 18963009 | |
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Inflammatory bowel disease | contraindication | 24526004 | DOID:0050589 |
| Ventricular tachycardia | contraindication | 25569003 | |
| Alcohol intoxication | contraindication | 25702006 | |
| Shock | contraindication | 27942005 | |
| Toxic megacolon | contraindication | 28536002 | DOID:1770 |
| Atony of colon | contraindication | 29479008 | |
| Hypercapnia | contraindication | 29596007 | |
| Dehydration | contraindication | 34095006 | |
| Hyperthyroidism | contraindication | 34486009 | DOID:7998 |
| Acute hepatitis | contraindication | 37871000 | |
| Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
| Disorder of gallbladder | contraindication | 39621005 | DOID:0060262 |
| Gastrointestinal ulcer | contraindication | 40845000 | |
| Hypothyroidism | contraindication | 40930008 | DOID:1459 |
| Complete trisomy 21 syndrome | contraindication | 41040004 | DOID:14250 |
| Conduction disorder of the heart | contraindication | 44808001 | |
| Low blood pressure | contraindication | 45007003 | |
| Achalasia of esophagus | contraindication | 45564002 | DOID:9164 |
| Chronic heart failure | contraindication | 48447003 | |
| Bradycardia | contraindication | 48867003 | |
| Acidosis | contraindication | 51387008 | |
| Gastrointestinal perforation | contraindication | 51875005 | |
| Vitamin K deficiency | contraindication | 52675005 | DOID:11249 |
| Nasal polyp | contraindication | 52756005 | |
| Coronary arteriosclerosis | contraindication | 53741008 | DOID:3393 |
| Paralytic ileus | contraindication | 55525008 | DOID:8442 |
| Peptic reflux disease | contraindication | 57643001 | |
| Acute nephropathy | contraindication | 58574008 | |
| Metabolic acidosis | contraindication | 59455009 | |
| Hepatic failure | contraindication | 59927004 | |
| Ulcerative colitis | contraindication | 64766004 | DOID:8577 |
| Blood coagulation disorder | contraindication | 64779008 | DOID:1247 |
| Arterial thrombosis | contraindication | 65198009 | |
| Drug AND/OR toxin-induced diarrhea | contraindication | 65979008 | |
| Substance abuse | contraindication | 66214007 | |
| Benign intracranial hypertension | contraindication | 68267002 | DOID:11459 |
| Poisoning by acetaminophen | contraindication | 70273001 | |
| Arteriosclerotic vascular disease | contraindication | 72092001 | |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Factor II deficiency | contraindication | 73975000 | |
| Reye's syndrome | contraindication | 74351001 | DOID:14525 |
| Gastrointestinal hemorrhage | contraindication | 74474003 | |
| Urethral stricture | contraindication | 76618002 | |
| Thrombotic thrombocytopenic purpura | contraindication | 78129009 | DOID:10772 |
| Spastic paralysis | contraindication | 78403003 | |
| Disturbance of salivary secretion | contraindication | 78948009 | |
| Decreased respiratory function | contraindication | 80954004 | |
| Injury of head | contraindication | 82271004 | |
| Chronic idiopathic constipation | contraindication | 82934008 | |
| Cor pulmonale | contraindication | 83291003 | DOID:8515 |
| Hiatal hernia | contraindication | 84089009 | DOID:12642 |
| Pulmonary emphysema | contraindication | 87433001 | |
| Gout | contraindication | 90560007 | DOID:13189 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Hemophilia | contraindication | 90935002 | |
| Myasthenia gravis | contraindication | 91637004 | DOID:437 |
| Anemia due to enzyme deficiency | contraindication | 111577008 | |
| Acute abdominal pain | contraindication | 116290004 | |
| Gastrointestinal obstruction | contraindication | 126765001 | |
| Neoplasm of brain | contraindication | 126952004 | DOID:1319 |
| von Willebrand disorder | contraindication | 128105004 | DOID:12531 |
| Seizure disorder | contraindication | 128613002 | |
| Autonomic dysreflexia | contraindication | 129618003 | |
| Bleeding | contraindication | 131148009 | |
| Drug-induced psychosis | contraindication | 191483003 | DOID:1742 |
| Partial atrioventricular block | contraindication | 195039008 | |
| Acute pancreatitis | contraindication | 197456007 | DOID:2913 |
| Coronary artery bypass graft | contraindication | 232717009 | |
| Myocardial dysfunction | contraindication | 233928007 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Hyporeninemic hypoaldosteronism | contraindication | 236464008 | |
| Bladder outflow obstruction | contraindication | 236645006 | |
| Morbid obesity | contraindication | 238136002 | DOID:11981 |
| Rhabdomyolysis | contraindication | 240131006 | |
| Pyloric obstruction | contraindication | 244815007 | |
| Benign prostatic hyperplasia | contraindication | 266569009 | |
| Retention of urine | contraindication | 267064002 | |
| Anemia | contraindication | 271737000 | DOID:2355 |
| Drowsy | contraindication | 271782001 | |
| Exacerbation of asthma | contraindication | 281239006 | |
| Pregnancy, function | contraindication | 289908002 | |
| Lesion of brain | contraindication | 301766008 | |
| Thrombocytopenic disorder | contraindication | 302215000 | DOID:1588 |
| Coma | contraindication | 371632003 | |
| Primary adrenocortical insufficiency | contraindication | 373662000 | |
| Operation on gastrointestinal tract | contraindication | 386621005 | |
| Hypoxia | contraindication | 389086002 | |
| Angle-closure glaucoma | contraindication | 392291006 | DOID:13550 |
| Cardiovascular event risk | contraindication | 395112001 | |
| Gastric ulcer | contraindication | 397825006 | DOID:10808 |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Chronic lung disease | contraindication | 413839001 | |
| Disorder of coronary artery | contraindication | 414024009 | |
| Traumatic injury | contraindication | 417746004 | |
| Central nervous system depression | contraindication | 418072004 | |
| Dysfunction of sphincter of Oddi | contraindication | 430887001 | |
| Hypertensive urgency | contraindication | 443482000 | |
| Acute erosive gastritis | contraindication | 444926003 | |
| Smokes tobacco daily | contraindication | 449868002 | |
| Acute Thromboembolic Stroke | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.64 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 100MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 10130591 | Nov. 20, 2023 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 100MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 8309060 | Nov. 20, 2023 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 120MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 10130591 | Nov. 20, 2023 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 120MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 8309060 | Nov. 20, 2023 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 20MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 10130591 | Nov. 20, 2023 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 20MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 8309060 | Nov. 20, 2023 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 30MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 10130591 | Nov. 20, 2023 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 30MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 8309060 | Nov. 20, 2023 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 40MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 10130591 | Nov. 20, 2023 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 40MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 8309060 | Nov. 20, 2023 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 60MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 10130591 | Nov. 20, 2023 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 60MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 8309060 | Nov. 20, 2023 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 80MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 10130591 | Nov. 20, 2023 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 80MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 8309060 | Nov. 20, 2023 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 100MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 11304909 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 100MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9095614 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 100MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9492390 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 100MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9492391 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 100MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9545380 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 120MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 11304909 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 120MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9095614 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 120MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9492390 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 120MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9492391 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 120MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9545380 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 20MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 11304909 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 20MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9095614 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 20MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9492390 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 20MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9492391 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 20MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9545380 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 30MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 11304909 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 30MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9095614 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 30MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9492390 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 30MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9492391 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 30MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9545380 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 40MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 11304909 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 40MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9095614 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 40MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9492390 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 40MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9492391 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 40MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9545380 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 60MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 11304909 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 60MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9095614 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 60MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9492390 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 60MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9492391 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 60MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9545380 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 80MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 11304909 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 80MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9095614 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 80MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9492390 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 80MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9492391 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 80MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 9545380 | Aug. 24, 2027 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 100MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 8808740 | Dec. 21, 2031 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 120MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 8808740 | Dec. 21, 2031 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 20MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 8808740 | Dec. 21, 2031 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 30MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 8808740 | Dec. 21, 2031 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 40MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 8808740 | Dec. 21, 2031 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 60MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 8808740 | Dec. 21, 2031 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 80MG | HYSINGLA ER | PURDUE PHARMA LP | N206627 | Nov. 20, 2014 | RX | TABLET, EXTENDED RELEASE | ORAL | 8808740 | Dec. 21, 2031 | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE |
| 10MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10028946 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 10MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10456393 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 10MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10722511 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 10MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9265760 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 10MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9326982 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 10MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9333201 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 10MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9339499 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 10MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9421200 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 10MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9433619 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 10MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9610286 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 15MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10028946 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 15MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10456393 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 15MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10722511 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 15MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9265760 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 15MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9326982 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 15MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9333201 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 15MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9339499 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 15MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9421200 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 15MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9433619 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 15MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9610286 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 20MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10028946 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 20MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10456393 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 20MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10722511 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 20MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9265760 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 20MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9326982 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 20MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9333201 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 20MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9339499 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 20MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9421200 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 20MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9433619 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 20MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9610286 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 30MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10028946 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 30MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10456393 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 30MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10722511 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 30MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9265760 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 30MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9326982 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 30MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9333201 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 30MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9339499 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 30MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9421200 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 30MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9433619 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 30MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9610286 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 40MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10028946 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 40MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10456393 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 40MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10722511 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 40MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9265760 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 40MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9326982 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 40MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9333201 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 40MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9339499 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 40MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9421200 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 40MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9433619 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 40MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9610286 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 50MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10028946 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 50MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10456393 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 50MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10722511 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 50MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9265760 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 50MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9326982 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 50MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9333201 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 50MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9339499 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 50MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9421200 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 50MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9433619 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 50MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9610286 | July 25, 2033 | TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT |
| 10MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10092559 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 10MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9452163 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 10MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9486451 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 10MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9713611 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 15MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10092559 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 15MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9452163 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 15MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9486451 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 15MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9713611 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 20MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10092559 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 20MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9452163 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 20MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9486451 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 20MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9713611 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 30MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10092559 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 30MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9452163 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 30MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9486451 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 30MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9713611 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 40MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10092559 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 40MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9452163 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 40MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9486451 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 40MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9713611 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 50MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 10092559 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 50MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9452163 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 50MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9486451 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 50MG | ZOHYDRO ER | RECRO GAINESVILLE | N202880 | Oct. 25, 2013 | DISCN | CAPSULE, EXTENDED RELEASE | ORAL | 9713611 | Sept. 12, 2034 | TREATMENT OF PAIN |
| 200MG/5ML;2.5MG/5ML | OBREDON | SOVEREIGN PHARMS | N205474 | Nov. 14, 2014 | DISCN | SOLUTION | ORAL | 10105324 | Nov. 13, 2035 | A METHOD OF INCREASING THE BIOAVAILABILITY OF GUAIFENESIN IN A SOLUTION CONTAINING 54% TO 66% BY WEIGHT OF PROPYLENE GLYCOL AND GLYCEROL, WHEREIN THE METHOD INCREASES THE CMAX BY AT LEAST 1.5 AND/OR INCREASES THE AUC (0-INF) BY AT LEAST 1.4 |
| 200MG/5ML;2.5MG/5ML | OBREDON | SOVEREIGN PHARMS | N205474 | Nov. 14, 2014 | DISCN | SOLUTION | ORAL | 9549907 | Nov. 13, 2035 | A METHOD OF INCREASING THE BIOAVAILABILITY OF GUAIFENESIN IN A SOLUTION CONTAINING 54% TO 66% BY WEIGHT OF PROPYLENE GLYCOL AND GLYCEROL, WHEREIN THE METHOD INCREASES THE CMAX BY AT LEAST 1.5 AND/OR INCREASES THE AUC (0-INF) BY AT LEAST 1.4 |
| 200MG/5ML;2.5MG/5ML | OBREDON | SOVEREIGN PHARMS | N205474 | Nov. 14, 2014 | DISCN | SOLUTION | ORAL | 9808431 | Nov. 13, 2035 | A METHOD OF INCREASING THE BIOAVAILABILITY OF GUAIFENESIN IN A SOLUTION CONTAINING 54% TO 66% BY WEIGHT OF PROPYLENE GLYCOL AND GLYCEROL, WHEREIN THE METHOD INCREASES THE CMAX BY AT LEAST 1.5 AND/OR INCREASES THE AUC (0-INF) BY AT LEAST 1.4 |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Mu-type opioid receptor | GPCR | AGONIST | Ki | 8.02 | CHEMBL | CHEMBL | |||
| Kappa-type opioid receptor | GPCR | AGONIST | Ki | 6.59 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4018165 | VUID |
| N0000146502 | NUI |
| D03725 | KEGG_DRUG |
| 34195-34-1 | SECONDARY_CAS_RN |
| 4018165 | VANDF |
| 4018473 | VANDF |
| 4019409 | VANDF |
| C0020264 | UMLSCUI |
| CHEBI:5779 | CHEBI |
| CHEMBL1457 | ChEMBL_ID |
| DB00956 | DRUGBANK_ID |
| CHEMBL3989677 | ChEMBL_ID |
| CHEMBL2062267 | ChEMBL_ID |
| D006853 | MESH_DESCRIPTOR_UI |
| 5284569 | PUBCHEM_CID |
| 7081 | IUPHAR_LIGAND_ID |
| 1700 | INN_ID |
| 6YKS4Y3WQ7 | UNII |
| 142439 | RXNORM |
| 13945 | MMSL |
| 4835 | MMSL |
| 4836 | MMSL |
| d03075 | MMSL |
| 001554 | NDDF |
| 001555 | NDDF |
| 001556 | NDDF |
| 20320002 | SNOMEDCT_US |
| 372671002 | SNOMEDCT_US |
| 3874004 | SNOMEDCT_US |
| 736862006 | SNOMEDCT_US |
| CHEMBL1201470 | ChEMBL_ID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-0772 | SOLUTION | 7.50 mg | ORAL | ANDA | 30 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-0772 | SOLUTION | 7.50 mg | ORAL | ANDA | 30 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-0772 | SOLUTION | 7.50 mg | ORAL | ANDA | 30 sections |
| Zamicet | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-1542 | SOLUTION | 5 mg | ORAL | ANDA | 30 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-1544 | SOLUTION | 5 mg | ORAL | ANDA | 30 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-1544 | SOLUTION | 5 mg | ORAL | ANDA | 30 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-1544 | SOLUTION | 5 mg | ORAL | ANDA | 30 sections |
| Zamicet | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-2313 | SOLUTION | 10 mg | ORAL | ANDA | 30 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-2316 | SOLUTION | 7.50 mg | ORAL | ANDA | 30 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-2316 | SOLUTION | 7.50 mg | ORAL | ANDA | 30 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-2316 | SOLUTION | 7.50 mg | ORAL | ANDA | 30 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-4772 | SOLUTION | 2.50 mg | ORAL | ANDA | 30 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-4772 | SOLUTION | 2.50 mg | ORAL | ANDA | 30 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-4772 | SOLUTION | 2.50 mg | ORAL | ANDA | 30 sections |
| Hydrocodone Bitartrate and Homatropine Methylbromide | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0121-4811 | SYRUP | 5 mg | ORAL | ANDA | 35 sections |
| TussiCaps | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0187-0054 | CAPSULE, EXTENDED RELEASE | 5 mg | ORAL | ANDA | 24 sections |
| TussiCaps | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0187-0108 | CAPSULE, EXTENDED RELEASE | 10 mg | ORAL | ANDA | 24 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0245-0410 | TABLET | 5 mg | ORAL | ANDA | 37 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0245-0410 | TABLET | 5 mg | ORAL | ANDA | 37 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0245-0411 | TABLET | 7.50 mg | ORAL | ANDA | 37 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0245-0411 | TABLET | 7.50 mg | ORAL | ANDA | 37 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0245-0412 | TABLET | 10 mg | ORAL | ANDA | 37 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0245-0412 | TABLET | 10 mg | ORAL | ANDA | 37 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0254-2034 | TABLET | 5 mg | ORAL | ANDA | 34 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0254-2035 | TABLET | 7.50 mg | ORAL | ANDA | 34 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0254-2036 | TABLET | 10 mg | ORAL | ANDA | 34 sections |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0406-0123 | TABLET | 5 mg | ORAL | ANDA | 28 sections |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0406-0124 | TABLET | 7.50 mg | ORAL | ANDA | 28 sections |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0406-0125 | TABLET | 10 mg | ORAL | ANDA | 28 sections |
| Hydrocodone Bitartrate and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0406-0376 | TABLET | 5 mg | ORAL | ANDA | 27 sections |