hydrocodone ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
1386 125-29-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • hydrocodone
  • dihydrocodeinone
  • hydrocodon
  • multacodin
  • hydrocodone bitartrate
  • hydrocodone polistirex
Narcotic analgesic related to CODEINE, but more potent and more addicting by weight. It is used also as cough suppressant.
  • Molecular weight: 299.37
  • Formula: C18H21NO3
  • CLOGP: 1.13
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 38.77
  • ALOGS: -2.57
  • ROTB: 1

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
15 mg O

ADMET properties:

PropertyValueReference
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 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 80 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
March 23, 1943 FDA ENDO PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 840.54 10.62 858 52994 131031 50420241
Cholecystitis chronic 440.07 10.62 212 53640 9457 50541815
Toxicity to various agents 343.43 10.62 721 53131 211778 50339494
Drug hypersensitivity 272.02 10.62 729 53123 250281 50300991
Cardio-respiratory arrest 234.62 10.62 288 53564 53604 50497668
Injury 193.10 10.62 249 53603 48676 50502596
Emotional distress 184.64 10.62 188 53664 28475 50522797
Cholelithiasis 168.57 10.62 205 53647 37768 50513504
Respiratory arrest 163.41 10.62 180 53672 29829 50521443
Drug abuse 157.26 10.62 251 53601 59595 50491677
Gallbladder disorder 156.34 10.62 135 53717 16607 50534665
Anxiety 152.51 10.62 475 53377 177131 50374141
Contraindicated product administered 140.02 10.62 4 53848 148954 50402318
Deep vein thrombosis 131.32 10.62 260 53592 73044 50478228
Maternal exposure during pregnancy 118.83 10.62 15 53837 159763 50391509
Depression 112.34 10.62 409 53443 165014 50386258
Intentional product misuse 109.26 10.62 186 53666 46548 50504724
Drug intolerance 101.95 10.62 53 53799 219051 50332221
Biliary dyskinesia 95.52 10.62 49 53803 2501 50548771
Synovitis 93.63 10.62 11 53841 123854 50427418
Off label use 90.07 10.62 236 53616 474190 50077082
Hand deformity 89.59 10.62 4 53848 100195 50451077
Systemic lupus erythematosus 89.55 10.62 20 53832 140602 50410670
Glossodynia 88.01 10.62 10 53842 115559 50435713
Infusion related reaction 86.60 10.62 36 53816 169521 50381751
Treatment failure 84.83 10.62 21 53831 137616 50413656
Gallbladder injury 76.41 10.62 34 53818 1260 50550012
Lower respiratory tract infection 73.08 10.62 8 53844 95193 50456079
Pulmonary embolism 72.83 10.62 256 53596 101448 50449824
Drug ineffective 69.46 10.62 550 53302 818783 49732489
Cardiac arrest 68.23 10.62 220 53632 83431 50467841
Joint swelling 63.42 10.62 102 53750 245184 50306088
Drug withdrawal syndrome 62.84 10.62 103 53749 24978 50526294
Pericarditis 61.98 10.62 6 53846 78683 50472589
Accidental death 60.98 10.62 32 53820 1712 50549560
Drug dependence 60.48 10.62 89 53763 19670 50531602
Wound 56.40 10.62 21 53831 105773 50445499
Death 55.91 10.62 560 53292 324819 50226453
Accidental overdose 55.54 10.62 85 53767 19448 50531824
Inadequate analgesia 54.58 10.62 34 53818 2524 50548748
Overdose 49.59 10.62 224 53628 99503 50451769
Discomfort 47.77 10.62 28 53824 108352 50442920
Rash 47.72 10.62 272 53580 437199 50114073
Neutropenia 45.77 10.62 54 53798 147911 50403361
Product use issue 45.76 10.62 55 53797 149420 50401852
C-reactive protein increased 45.34 10.62 8 53844 66466 50484806
Anhedonia 44.83 10.62 53 53799 9471 50541801
Exposure during pregnancy 44.48 10.62 38 53814 120977 50430295
Drug abuser 44.32 10.62 31 53821 2797 50548475
Gallbladder hypofunction 41.62 10.62 17 53835 508 50550764
Rheumatoid factor positive 41.46 10.62 3 53849 49856 50501416
Biliary colic 40.38 10.62 31 53821 3228 50548044
Arthropathy 39.53 10.62 67 53785 157839 50393433
Abdominal discomfort 38.14 10.62 123 53729 231518 50319754
Nasopharyngitis 37.99 10.62 94 53758 192833 50358439
Coronary artery disease 37.88 10.62 92 53760 29634 50521638
Cholecystitis 37.53 10.62 59 53793 13812 50537460
Hepatic enzyme increased 37.50 10.62 55 53797 137325 50413947
Helicobacter infection 36.12 10.62 5 53847 49697 50501575
Insomnia 34.96 10.62 311 53541 174554 50376718
Scar 34.40 10.62 52 53800 11766 50539506
Mental status changes 33.83 10.62 100 53752 36172 50515100
Condition aggravated 33.80 10.62 182 53670 296876 50254396
Back pain 33.61 10.62 370 53482 219660 50331612
Respiratory depression 32.37 10.62 51 53801 11959 50539313
Pyrexia 32.09 10.62 255 53597 379948 50171324
Febrile neutropenia 31.99 10.62 34 53818 97633 50453639
Rheumatoid arthritis 31.65 10.62 110 53742 202440 50348832
Acute lung injury 30.95 10.62 19 53833 1374 50549898
Cerebrovascular accident 30.72 10.62 189 53663 94491 50456781
Cholesterosis 30.71 10.62 13 53839 426 50550846
Gallbladder cholesterolosis 30.15 10.62 15 53837 717 50550555
Chest pain 29.60 10.62 303 53549 176579 50374693
Therapeutic product effect decreased 29.42 10.62 63 53789 135987 50415285
Muscle injury 28.77 10.62 3 53849 37108 50514164
Alopecia 28.49 10.62 149 53703 244898 50306374
Hypersensitivity 27.81 10.62 126 53726 215035 50336237
Infection 27.65 10.62 93 53759 172861 50378411
Muscle spasms 27.01 10.62 227 53625 125326 50425946
Intervertebral disc protrusion 26.93 10.62 64 53788 20329 50530943
Dependence 25.82 10.62 19 53833 1856 50549416
Drug screen positive 25.02 10.62 24 53828 3378 50547894
Feeling abnormal 24.45 10.62 222 53630 125270 50426002
Intervertebral disc degeneration 24.38 10.62 48 53804 13413 50537859
Nausea 24.29 10.62 948 52904 704450 49846822
Folliculitis 24.12 10.62 6 53846 39219 50512053
Electrocardiogram QT prolonged 23.43 10.62 13 53839 51873 50499399
Poisoning 23.34 10.62 45 53807 12384 50538888
Swelling 22.86 10.62 123 53729 200749 50350523
Thrombocytopenia 22.26 10.62 66 53786 127607 50423665
Cardiac failure 22.19 10.62 29 53823 76011 50475261
Migraine 21.78 10.62 146 53706 75134 50476138
Pain in extremity 21.61 10.62 409 53443 272456 50278816
Uterine perforation 21.24 10.62 30 53822 6385 50544887
Renal impairment 20.92 10.62 30 53822 75631 50475641
Mental disorder 20.86 10.62 61 53791 21930 50529342
Drug interaction 20.69 10.62 126 53726 199495 50351777
Product use in unapproved indication 20.10 10.62 60 53792 115759 50435513
Musculoskeletal stiffness 19.90 10.62 70 53782 128411 50422861
Leukopenia 19.45 10.62 26 53826 67502 50483770
Gamma-glutamyltransferase increased 19.27 10.62 4 53848 29619 50521653
Back injury 18.98 10.62 30 53822 7055 50544217
Sleep disorder due to general medical condition, insomnia type 18.97 10.62 5 53847 31442 50519830
Thrombosis 18.44 10.62 112 53740 55721 50495551
Pain 18.26 10.62 771 53081 578132 49973140
Hepatic function abnormal 18.24 10.62 6 53846 32675 50518597
Chronic obstructive pulmonary disease 18.17 10.62 108 53744 53327 50497945
Abortion spontaneous 18.10 10.62 11 53841 41761 50509511
Road traffic accident 18.01 10.62 62 53790 24290 50526982
Interstitial lung disease 17.98 10.62 18 53834 53158 50498114
Hepatocellular injury 17.96 10.62 3 53849 25944 50525328
Gastrooesophageal reflux disease 17.95 10.62 141 53711 76287 50474985
Cholecystectomy 17.86 10.62 34 53818 9269 50542003
Abnormal dreams 17.67 10.62 34 53818 9343 50541929
Cholecystitis acute 17.55 10.62 29 53823 7077 50544195
Peripheral swelling 17.39 10.62 138 53714 205798 50345474
Lactic acidosis 17.14 10.62 7 53845 33348 50517924
Respiratory muscle weakness 17.13 10.62 6 53846 116 50551156
Withdrawal syndrome 16.88 10.62 49 53803 17541 50533731
Ill-defined disorder 16.83 10.62 20 53832 54634 50496638
Device expulsion 16.61 10.62 5 53847 28817 50522455
Purpura senile 16.51 10.62 9 53843 520 50550752
Tarsal tunnel syndrome 16.35 10.62 9 53843 530 50550742
Dehydration 16.28 10.62 240 53612 152209 50399063
Memory impairment 15.76 10.62 141 53711 79219 50472053
Peptic ulcer 15.74 10.62 20 53832 3846 50547426
Hypoaesthesia 15.46 10.62 205 53647 127052 50424220
Cholestasis 15.39 10.62 4 53848 25397 50525875
Tooth loss 14.99 10.62 25 53827 6145 50545127
Drug tolerance 14.63 10.62 22 53830 4954 50546318
Septic shock 14.53 10.62 24 53828 57151 50494121
Fear 14.42 10.62 41 53811 14508 50536764
Emotional disorder 14.41 10.62 36 53816 11800 50539472
Erythema 14.34 10.62 94 53758 146320 50404952
Neck injury 14.34 10.62 13 53839 1704 50549568
Lumbosacral plexopathy 14.25 10.62 3 53849 6 50551266
Pulmonary infarction 14.12 10.62 15 53837 2383 50548889
Vestibular disorder 13.42 10.62 11 53841 1258 50550014
Resorption bone increased 13.37 10.62 10 53842 1001 50550271
Extradural haematoma 13.22 10.62 12 53840 1575 50549697
Hyponatraemia 13.19 10.62 55 53797 96084 50455188
Blood pressure systolic increased 13.17 10.62 11 53841 35438 50515834
Major depression 13.02 10.62 25 53827 6859 50544413
Accidental poisoning 12.84 10.62 8 53844 594 50550678
Myocardial infarction 12.79 10.62 148 53704 88879 50462393
Stomatitis 12.69 10.62 60 53792 101284 50449988
Abdominal pain 12.64 10.62 335 53517 235893 50315379
Hyperlipidaemia 12.48 10.62 44 53808 17446 50533826
Hyperkalaemia 12.39 10.62 20 53832 48069 50503203
Bone marrow failure 12.36 10.62 7 53845 27617 50523655
Toxic leukoencephalopathy 12.36 10.62 8 53844 635 50550637
Altered state of consciousness 12.27 10.62 4 53848 21906 50529366
Nervousness 12.18 10.62 60 53792 27591 50523681
Product complaint 12.04 10.62 33 53819 11433 50539839
Rotator cuff syndrome 11.90 10.62 33 53819 11511 50539761
Nail growth abnormal 11.82 10.62 7 53845 474 50550798
Osteonecrosis 11.49 10.62 51 53801 22466 50528806
Drug-induced liver injury 11.36 10.62 8 53844 28087 50523185
Restless legs syndrome 11.34 10.62 40 53812 15857 50535415
Fat intolerance 11.32 10.62 3 53849 21 50551251
Muscle atrophy 11.29 10.62 22 53830 6099 50545173
Psychological trauma 11.28 10.62 9 53843 991 50550281
Transverse sinus thrombosis 11.27 10.62 7 53845 517 50550755
Muscle tightness 11.21 10.62 30 53822 10250 50541022
Blood pressure fluctuation 11.14 10.62 13 53839 35810 50515462
Multiple organ dysfunction syndrome 11.13 10.62 23 53829 50314 50500958
Red blood cell sedimentation rate increased 11.09 10.62 9 53843 29407 50521865
Intervertebral disc disorder 11.04 10.62 18 53834 4342 50546930
Chronic fatigue syndrome 11.01 10.62 9 53843 1026 50550246
Crying 11.00 10.62 47 53805 20369 50530903
Intestinal ischaemia 10.94 10.62 23 53829 6734 50544538
Tendon disorder 10.90 10.62 20 53832 5302 50545970
Chronic kidney disease 10.82 10.62 76 53776 39695 50511577
Nerve injury 10.80 10.62 26 53826 8324 50542948
Compression fracture 10.79 10.62 21 53831 5816 50545456

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 467.11 11.69 519 30115 89727 29454166
Toxicity to various agents 261.67 11.69 563 30071 173098 29370795
Accidental overdose 212.71 11.69 163 30471 17430 29526463
Drug abuse 199.22 11.69 322 30312 79561 29464332
Cardio-respiratory arrest 181.21 11.69 242 30392 50359 29493534
Drug dependence 159.84 11.69 149 30485 20832 29523061
Respiratory arrest 133.85 11.69 149 30485 25684 29518209
Drug abuser 109.77 11.69 61 30573 3766 29540127
Off label use 89.83 11.69 108 30526 300692 29243201
Overdose 82.26 11.69 224 30410 79595 29464298
Drug withdrawal syndrome 81.78 11.69 97 30537 17887 29526006
Intentional product misuse 79.87 11.69 135 30499 34526 29509367
Anxiety 66.51 11.69 217 30417 85148 29458745
Depression 65.04 11.69 215 30419 84932 29458961
Inadequate analgesia 61.96 11.69 37 30597 2617 29541276
Emotional distress 55.17 11.69 70 30564 13825 29530068
Cardiac arrest 49.94 11.69 198 30436 85393 29458500
Respiratory depression 47.28 11.69 64 30570 13459 29530434
Drug hypersensitivity 45.47 11.69 165 30469 68241 29475652
Gun shot wound 44.57 11.69 22 30612 1063 29542830
Insomnia 43.73 11.69 195 30439 88566 29455327
Pyrexia 38.77 11.69 160 30474 287462 29256431
Coronary artery disease 34.96 11.69 113 30521 44077 29499816
C-reactive protein increased 34.70 11.69 3 30631 44260 29499633
Accidental death 33.25 11.69 23 30611 2095 29541798
Pain 33.05 11.69 296 30338 171136 29372757
Drug tolerance 32.91 11.69 23 30611 2130 29541763
Ventricular hypertrophy 31.90 11.69 30 30604 4234 29539659
Chest pain 31.40 11.69 211 30423 111762 29432131
Drug screen positive 30.88 11.69 28 30606 3773 29540120
Drug interaction 29.65 11.69 105 30529 197280 29346613
General physical health deterioration 29.44 11.69 38 30596 102819 29441074
Product use in unapproved indication 29.36 11.69 28 30606 86847 29457046
Myocardial infarction 28.65 11.69 204 30430 110092 29433801
Death 28.28 11.69 504 30130 341580 29202313
Substance abuse 28.22 11.69 35 30599 6752 29537141
Back pain 27.63 11.69 191 30443 102093 29441800
Lumbar radiculopathy 27.42 11.69 14 30620 727 29543166
Intervertebral disc degeneration 26.62 11.69 30 30604 5234 29538659
Dependence 25.65 11.69 15 30619 1020 29542873
Hepatic function abnormal 25.21 11.69 5 30629 39254 29504639
Arteriosclerosis 25.01 11.69 41 30593 10215 29533678
Neutropenia 24.07 11.69 64 30570 131647 29412246
Cardiac failure 24.05 11.69 28 30606 79259 29464634
Hypoaesthesia 23.74 11.69 114 30520 53353 29490540
Spinal osteoarthritis 23.63 11.69 31 30603 6325 29537568
Renal impairment 23.32 11.69 30 30604 81303 29462590
Poisoning 21.78 11.69 38 30596 9955 29533938
Interstitial lung disease 21.44 11.69 17 30617 57701 29486192
Pain in extremity 21.41 11.69 191 30443 110242 29433651
Back injury 21.38 11.69 22 30612 3462 29540431
Acute kidney injury 20.98 11.69 175 30459 265092 29278801
Arteriosclerosis coronary artery 20.16 11.69 38 30596 10567 29533326
Carpal tunnel syndrome 20.04 11.69 23 30611 4091 29539802
Pulmonary congestion 19.36 11.69 41 30593 12395 29531498
Gastrooesophageal reflux disease 19.26 11.69 74 30560 31422 29512471
Condition aggravated 19.26 11.69 82 30552 146213 29397680
Environmental exposure 19.20 11.69 8 30626 259 29543634
Intervertebral disc protrusion 18.94 11.69 33 30601 8637 29535256
Foetal exposure during pregnancy 18.50 11.69 6 30628 33861 29510032
Antasthmatic drug level 18.42 11.69 5 30629 40 29543853
Analgesic drug level 18.42 11.69 5 30629 40 29543853
Leukopenia 18.40 11.69 18 30616 55185 29488708
Road traffic accident 18.37 11.69 46 30588 15515 29528378
Mental status changes 18.13 11.69 78 30556 34849 29509044
Hypoxic-ischaemic encephalopathy 17.66 11.69 22 30612 4262 29539631
Nervousness 17.29 11.69 37 30597 11269 29532624
Blood cholesterol increased 17.27 11.69 45 30589 15550 29528343
Febrile neutropenia 16.62 11.69 60 30574 112180 29431713
Rotator cuff syndrome 16.58 11.69 23 30611 4947 29538946
Cardiomegaly 16.56 11.69 41 30593 13735 29530158
Plasma cell myeloma 16.37 11.69 79 30555 37036 29506857
Walking disability 16.27 11.69 10 30624 745 29543148
Treatment failure 16.25 11.69 9 30625 36930 29506963
Hyperlipidaemia 15.69 11.69 38 30596 12552 29531341
Pulmonary oedema 15.41 11.69 86 30548 42649 29501244
Reaction to excipient 15.31 11.69 8 30626 436 29543457
Back disorder 14.73 11.69 24 30610 5949 29537944
Thrombocytopenia 14.59 11.69 81 30553 134742 29409151
Complex regional pain syndrome 14.55 11.69 8 30626 483 29543410
Mitral valve incompetence 14.36 11.69 38 30596 13255 29530638
Haemorrhoids 14.33 11.69 35 30599 11622 29532271
Coronary artery stenosis 14.21 11.69 29 30605 8544 29535349
Thymus disorder 13.73 11.69 3 30631 8 29543885
Anger 13.71 11.69 33 30601 10857 29533036
Osteomyelitis 13.61 11.69 38 30596 13671 29530222
Liver disorder 13.35 11.69 6 30628 27743 29516150
Phantom limb syndrome 13.16 11.69 6 30628 242 29543651
Groin pain 12.82 11.69 20 30614 4778 29539115
Burning sensation 12.82 11.69 41 30593 15897 29527996
Irritability 12.69 11.69 51 30583 22101 29521792
Neutrophil count decreased 12.55 11.69 16 30618 43551 29500342
Alanine aminotransferase increased 12.55 11.69 35 30599 70909 29472984
Lower respiratory tract infection 12.34 11.69 6 30628 26496 29517397
Decreased interest 12.23 11.69 13 30621 2125 29541768
Costochondritis 12.13 11.69 7 30627 464 29543429
Dental caries 11.98 11.69 18 30616 4162 29539731
Disseminated intravascular coagulation 11.91 11.69 3 30631 19977 29523916
Myofascial pain syndrome 11.89 11.69 6 30628 304 29543589
Bronchitis 11.86 11.69 72 30562 36796 29507097
Injury 11.85 11.69 45 30589 19001 29524892
Product use issue 11.84 11.69 22 30612 51422 29492471
Atelectasis 11.84 11.69 39 30595 15353 29528540
Learning disability 11.74 11.69 6 30628 312 29543581

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 1552.88 10.42 1478 62606 222936 64211712
Toxicity to various agents 633.26 10.42 1221 62863 362292 64072356
Cardio-respiratory arrest 516.87 10.42 560 63524 97833 64336815
Cholecystitis chronic 403.31 10.42 193 63891 9094 64425554
Drug abuse 371.24 10.42 551 63533 131823 64302825
Respiratory arrest 319.81 10.42 325 63759 52660 64381988
Accidental overdose 245.91 10.42 229 63855 33328 64401320
Emotional distress 222.79 10.42 224 63860 35814 64398834
Intentional product misuse 218.52 10.42 312 63772 71983 64362665
Drug hypersensitivity 204.01 10.42 608 63476 237207 64197441
Injury 193.78 10.42 258 63826 55734 64378914
Anxiety 182.24 10.42 527 63557 202122 64232526
Gallbladder disorder 152.09 10.42 130 63954 16900 64417748
Depression 146.17 10.42 457 63627 182834 64251814
Off label use 143.80 10.42 256 63828 632550 63802098
Cardiac arrest 140.67 10.42 403 63681 153661 64280987
Drug abuser 138.79 10.42 81 64003 5727 64428921
Cholelithiasis 136.87 10.42 196 63888 45310 64389338
Drug dependence 134.91 10.42 166 63918 33146 64401502
Death 119.44 10.42 854 63230 481851 63952797
Overdose 113.75 10.42 383 63701 159183 64275465
Accidental death 97.15 10.42 55 64029 3670 64430978
Biliary dyskinesia 96.04 10.42 47 64037 2325 64432323
Deep vein thrombosis 95.80 10.42 275 63809 104907 64329741
Drug withdrawal syndrome 94.41 10.42 135 63949 31156 64403492
Contraindicated product administered 90.07 10.42 4 64080 107825 64326823
Inadequate analgesia 80.85 10.42 50 64034 3928 64430720
Coronary artery disease 79.98 10.42 182 63902 60251 64374397
Infusion related reaction 79.37 10.42 32 64052 164435 64270213
Gallbladder injury 79.19 10.42 33 64051 1115 64433533
Maternal exposure during pregnancy 78.65 10.42 4 64080 95880 64338768
Respiratory depression 74.96 10.42 104 63980 23339 64411309
Pyrexia 74.76 10.42 294 63790 558350 63876298
Synovitis 73.01 10.42 7 64077 99083 64335565
Drug intolerance 69.72 10.42 51 64033 187941 64246707
C-reactive protein increased 66.62 10.42 8 64076 94901 64339747
Neutropenia 57.83 10.42 93 63991 239531 64195117
Lower respiratory tract infection 57.36 10.42 12 64072 94602 64340046
Treatment failure 54.31 10.42 24 64060 116792 64317856
Drug ineffective 53.46 10.42 556 63528 839691 63594957
Insomnia 51.02 10.42 354 63730 197482 64237166
Chest pain 48.88 10.42 401 63683 235579 64199069
Hand deformity 47.41 10.42 4 64080 62767 64371881
Poisoning 47.31 10.42 81 64003 21798 64412850
Cardiac failure 46.41 10.42 38 64046 132335 64302313
Product use in unapproved indication 46.02 10.42 65 64019 176553 64258095
Pulmonary embolism 45.77 10.42 275 63809 146081 64288567
Pain 45.45 10.42 787 63297 552724 63881924
Febrile neutropenia 45.10 10.42 73 64011 187584 64247064
Drug interaction 44.93 10.42 196 63888 361887 64072761
Gallbladder hypofunction 44.86 10.42 17 64067 445 64434203
Renal impairment 43.44 10.42 42 64042 134975 64299673
Gun shot wound 42.83 10.42 21 64063 1043 64433605
Joint swelling 41.96 10.42 95 63989 215287 64219361
Drug tolerance 41.64 10.42 40 64044 6045 64428603
Interstitial lung disease 41.02 10.42 23 64061 97709 64336939
Back pain 40.98 10.42 404 63680 249767 64184881
Drug screen positive 39.84 10.42 38 64046 5691 64428957
Mental status changes 38.50 10.42 141 63943 61021 64373627
Systemic lupus erythematosus 37.59 10.42 15 64069 77597 64357051
Myocardial infarction 36.61 10.42 286 63798 165535 64269113
Thrombocytopenia 35.75 10.42 109 63975 223692 64210956
Leukopenia 35.56 10.42 29 64055 101213 64333435
Hepatic function abnormal 35.38 10.42 10 64074 64303 64370345
Rash 35.27 10.42 289 63795 458260 63976388
Acute kidney injury 35.07 10.42 282 63802 448958 63985690
Cerebrovascular accident 34.74 10.42 245 63839 137338 64297310
Gamma-glutamyltransferase increased 34.26 10.42 4 64080 48506 64386142
Pericarditis 33.87 10.42 10 64074 62506 64372142
Cholestasis 33.50 10.42 3 64081 44869 64389779
Condition aggravated 33.26 10.42 225 63859 372201 64062447
Exposure during pregnancy 33 10.42 18 64066 77657 64356991
Pain in extremity 32.88 10.42 452 63632 302633 64132015
Nasopharyngitis 32.39 10.42 94 63990 195979 64238669
Biliary colic 32.20 10.42 27 64057 3417 64431231
Scar 32.18 10.42 52 64032 13346 64421302
Glossodynia 32.16 10.42 12 64072 64684 64369964
Back injury 31.95 10.42 39 64045 7718 64426930
Gastrooesophageal reflux disease 31.81 10.42 165 63919 82978 64351670
Drug reaction with eosinophilia and systemic symptoms 30.63 10.42 8 64076 54209 64380439
Road traffic accident 30.53 10.42 83 64001 30662 64403986
Intervertebral disc protrusion 30.32 10.42 64 64020 20127 64414521
Anhedonia 29.97 10.42 51 64033 13655 64420993
Dependence 29.09 10.42 21 64063 2134 64432514
Hypersensitivity 29.06 10.42 99 63985 196353 64238295
Ventricular hypertrophy 28.87 10.42 34 64050 6482 64428166
Gallbladder cholesterolosis 28.46 10.42 13 64071 550 64434098
Arteriosclerosis 28.24 10.42 54 64030 15823 64418825
Substance abuse 27.89 10.42 40 64044 9252 64425396
Eosinophilia 27.24 10.42 3 64081 38073 64396575
Erythema 27.17 10.42 95 63989 186975 64247673
Product use issue 27.10 10.42 70 64014 151645 64283003
Hyperlipidaemia 26.91 10.42 66 64018 22910 64411738
Cholesterosis 26.90 10.42 11 64073 354 64434294
Muscle spasms 26.71 10.42 235 63849 140788 64293860
Toxic epidermal necrolysis 26.41 10.42 3 64081 37163 64397485
Uterine perforation 25.18 10.42 30 64054 5790 64428858
Helicobacter infection 25.11 10.42 4 64080 38358 64396290
Lactic acidosis 24.99 10.42 15 64069 61395 64373253
Cholecystectomy 24.73 10.42 35 64049 7997 64426651
Hyponatraemia 24.58 10.42 71 64013 148268 64286380
Feeling abnormal 24.46 10.42 221 63863 133381 64301267
Intervertebral disc degeneration 23.80 10.42 45 64039 13075 64421573
Nervousness 23.77 10.42 74 64010 29482 64405166
Cholecystitis 23.63 10.42 57 64027 19579 64415069
Hypoaesthesia 23.41 10.42 226 63858 138882 64295766
Hepatocellular injury 23.15 10.42 8 64076 45227 64389421
Rash maculo-papular 22.91 10.42 9 64075 47017 64387631
Rotator cuff syndrome 22.55 10.42 42 64042 12065 64422583
Hepatic enzyme increased 22.41 10.42 61 64023 129882 64304766
Rheumatoid factor positive 22.08 10.42 4 64080 34934 64399714
Arteriosclerosis coronary artery 21.92 10.42 48 64036 15481 64419167
Hyperkalaemia 21.87 10.42 42 64042 101087 64333561
General physical health deterioration 21.63 10.42 117 63967 204308 64230340
Peripheral vascular disorder 21.41 10.42 31 64053 7230 64427418
Wound 21.07 10.42 27 64057 76450 64358198
Septic shock 20.93 10.42 46 64038 105391 64329257
Coronary artery stenosis 20.93 10.42 39 64045 11209 64423439
Stomatitis 20.80 10.42 49 64035 109556 64325092
Acute lung injury 20.69 10.42 19 64065 2712 64431936
Bone marrow failure 20.53 10.42 11 64073 47941 64386707
Neutrophil count decreased 20.50 10.42 28 64056 77168 64357480
Tarsal tunnel syndrome 20.43 10.42 10 64074 495 64434153
Drug-induced liver injury 20.29 10.42 11 64073 47632 64387016
Drug resistance 20.17 10.42 5 64079 35097 64399551
Chronic obstructive pulmonary disease 20.00 10.42 130 63954 70918 64363730
Spinal osteoarthritis 19.87 10.42 44 64040 14297 64420351
Migraine 19.72 10.42 118 63966 62559 64372089
Multiple organ dysfunction syndrome 19.51 10.42 45 64039 101368 64333280
Infection 19.46 10.42 106 63978 184774 64249874
Mental disorder 19.26 10.42 64 64020 26381 64408267
Lumbar radiculopathy 19.01 10.42 15 64069 1742 64432906
Electrocardiogram QT prolonged 18.98 10.42 31 64053 79417 64355231
Altered state of consciousness 18.89 10.42 7 64077 37895 64396753
Blood pressure systolic increased 18.86 10.42 13 64071 49440 64385208
Antasthmatic drug level 18.63 10.42 5 64079 40 64434608
Rheumatoid arthritis 18.52 10.42 92 63992 164202 64270446
Pulmonary congestion 18.48 10.42 59 64025 23821 64410827
Analgesic drug level 18.21 10.42 5 64079 44 64434604
Pancytopenia 18.09 10.42 77 64007 143232 64291416
Thrombosis 17.94 10.42 126 63958 70516 64364132
Memory impairment 17.92 10.42 146 63938 85536 64349112
Mitral valve incompetence 17.89 10.42 61 64023 25477 64409171
Liver disorder 17.85 10.42 16 64068 53335 64381313
Emotional disorder 17.83 10.42 39 64045 12568 64422080
Pneumocystis jirovecii pneumonia 17.82 10.42 3 64081 27631 64407017
Back disorder 17.79 10.42 34 64050 9956 64424692
Purpura senile 17.38 10.42 9 64075 502 64434146
Sepsis 17.29 10.42 146 63938 230195 64204453
Environmental exposure 17.26 10.42 8 64076 350 64434298
Oxygen saturation decreased 17.24 10.42 52 64032 107124 64327524
Epilepsy 17.04 10.42 6 64078 33525 64401123
Inflammation 17.03 10.42 24 64060 65276 64369372
Carpal tunnel syndrome 17.00 10.42 44 64040 15784 64418864
Blood pressure fluctuation 16.83 10.42 16 64068 51855 64382793
Melaena 16.82 10.42 17 64067 53531 64381117
Transaminases increased 16.64 10.42 12 64072 44582 64390066
Angina unstable 16.62 10.42 43 64041 15424 64419224
Blood cholesterol increased 16.22 10.42 95 63989 49971 64384677
Cardiomegaly 16.09 10.42 56 64028 23628 64411020
Liver injury 15.83 10.42 5 64079 29927 64404721
Accident 15.67 10.42 26 64058 6820 64427828
Platelet count decreased 15.10 10.42 101 63983 167610 64267038
Angioedema 14.88 10.42 24 64060 61797 64372851
Fear 14.86 10.42 49 64035 20122 64414526
Muscle injury 14.74 10.42 4 64080 26433 64408215
Discomfort 14.68 10.42 37 64047 80841 64353807
Chronic fatigue syndrome 14.68 10.42 11 64073 1184 64433464
Amnesia 14.63 10.42 90 63994 48179 64386469
Postinfarction angina 14.59 10.42 4 64080 35 64434613
Intervertebral disc disorder 14.58 10.42 20 64064 4437 64430211
Peptic ulcer 14.53 10.42 22 64062 5341 64429307
Anaphylactic shock 14.45 10.42 6 64078 30322 64404326
Respiratory disorder 14.44 10.42 9 64075 36102 64398546
Anaphylactic reaction 14.43 10.42 29 64055 68635 64366013
Major depression 14.41 10.42 27 64057 7789 64426859
Multiple injuries 14.26 10.42 17 64067 3282 64431366
Folliculitis 14.26 10.42 6 64078 30071 64404577
COVID-19 14.13 10.42 27 64057 65113 64369535
Copper deficiency 14.09 10.42 5 64079 108 64434540
Lymphopenia 14.09 10.42 4 64080 25653 64408995
Obstructive airways disorder 13.92 10.42 3 64081 23182 64411466
Neurotoxicity 13.76 10.42 5 64079 27399 64407249
Extradural haematoma 13.61 10.42 15 64069 2661 64431987
Irritability 13.41 10.42 72 64012 36674 64397974
Crying 13.22 10.42 47 64037 20043 64414605
Drug eruption 13.13 10.42 10 64074 36126 64398522
Cerebral haemorrhage 13.10 10.42 19 64065 51071 64383577
Stevens-Johnson syndrome 13.06 10.42 9 64075 34240 64400408
Withdrawal syndrome 13.00 10.42 52 64032 23440 64411208
Pulmonary infarction 12.95 10.42 16 64068 3206 64431442
Sleep disorder due to general medical condition, insomnia type 12.84 10.42 5 64079 26265 64408383
Resorption bone increased 12.70 10.42 10 64074 1158 64433490
Opiates positive 12.69 10.42 9 64075 889 64433759
Cholecystitis acute 12.64 10.42 32 64052 11328 64423320
Blood creatinine increased 12.61 10.42 81 64003 135701 64298947
Respiratory muscle weakness 12.56 10.42 6 64078 281 64434367
Hypoxic-ischaemic encephalopathy 12.32 10.42 24 64060 7128 64427520
Hernia 11.96 10.42 35 64049 13483 64421165
Cytokine release syndrome 11.90 10.42 3 64081 20826 64413822
Malabsorption 11.84 10.42 18 64066 4385 64430263
Dyspepsia 11.83 10.42 127 63957 80185 64354463
Neck injury 11.80 10.42 13 64071 2305 64432343
Heart rate decreased 11.79 10.42 23 64061 55044 64379604
Cardiogenic shock 11.75 10.42 9 64075 32418 64402230
Urticaria 11.67 10.42 92 63992 147225 64287423
Therapeutic product effect decreased 11.66 10.42 67 64017 115284 64319364
Hepatitis 11.64 10.42 17 64067 45565 64389083
Phantom limb syndrome 11.58 10.42 6 64078 335 64434313
Therapeutic product effect increased 11.50 10.42 10 64074 1330 64433318
Endometriosis 11.44 10.42 14 64070 2778 64431870
Post concussion syndrome 11.43 10.42 7 64077 540 64434108
Osteomyelitis 11.43 10.42 56 64028 27531 64407117
Circulatory collapse 11.43 10.42 10 64074 33722 64400926
Pulmonary oedema 11.40 10.42 124 63960 78550 64356098
Nausea 11.40 10.42 917 63167 784883 63649765
Muscle atrophy 11.39 10.42 28 64056 9730 64424918
Transient ischaemic attack 11.33 10.42 79 64005 44103 64390545
Complex regional pain syndrome 11.32 10.42 11 64073 1685 64432963
Osteoarthritis 11.19 10.42 104 63980 63232 64371416
Snake bite 11.18 10.42 3 64081 24 64434624
Tachycardia 11.13 10.42 95 63989 149484 64285164
Polyneuropathy 11.11 10.42 3 64081 19891 64414757
Respiratory distress 11.08 10.42 22 64062 52309 64382339
Laryngeal pain 10.98 10.42 20 64064 5648 64429000
Tooth loss 10.81 10.42 21 64063 6226 64428422
Myofascial pain syndrome 10.78 10.42 11 64073 1787 64432861
Neuropathy peripheral 10.64 10.42 170 63914 117355 64317293
Transverse sinus thrombosis 10.63 10.42 7 64077 613 64434035
Product complaint 10.62 10.42 31 64053 11923 64422725
Tendon disorder 10.61 10.42 21 64063 6311 64428337
Unresponsive to stimuli 10.60 10.42 86 63998 50307 64384341
Paraesthesia 10.51 10.42 190 63894 134332 64300316
Anger 10.50 10.42 37 64047 15704 64418944
Neutropenic sepsis 10.47 10.42 5 64079 23267 64411381
Coronary artery occlusion 10.46 10.42 34 64050 13857 64420791
Head injury 10.43 10.42 62 64022 32780 64401868
Fibromyalgia 10.43 10.42 66 64018 35665 64398983
Bronchopulmonary aspergillosis 10.43 10.42 3 64081 19082 64415566

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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 (View source of the data)

DiseaseRelationSNOMED_IDDOID
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.64 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Mu-type opioid receptor GPCR AGONIST Ki 8.02 CHEMBL CHEMBL
Kappa-type opioid receptor GPCR AGONIST Ki 6.59 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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
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 0121-4772 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 34 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0245-0411 TABLET 7.50 mg ORAL ANDA 34 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0245-0412 TABLET 10 mg ORAL ANDA 34 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
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0406-0377 TABLET 7.50 mg ORAL ANDA 27 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0406-0378 TABLET 10 mg ORAL ANDA 27 sections
Hydrocodone Bitartrate And Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0440-7605 TABLET 5 mg ORAL ANDA 30 sections
HYDROCODONE BITARTRATE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 0440-7610 TABLET 5 mg ORAL ANDA 27 sections
Hydromet HUMAN PRESCRIPTION DRUG LABEL 2 0472-1030 SOLUTION 5 mg ORAL ANDA 29 sections
Zamicet HUMAN PRESCRIPTION DRUG LABEL 2 0486-0771 SOLUTION 10 mg ORAL ANDA 30 sections
Zamicet HUMAN PRESCRIPTION DRUG LABEL 2 0486-4771 SOLUTION 5 mg ORAL ANDA 30 sections