hydrocodone ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 1.292 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.865 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 21.232 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 14.859 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 74.780 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 77.970 % High 1
herg hERG pIC50 4.883 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 2.032 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 16.711 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 68.380 % High 1
kinase-safety-class ACVR2B,AKT2,AKT3,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK2,CDK4,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,JAK2,JAK3,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPKAPK2,MET,NTRK2,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIM2,PRKDC,SIK2,SIK3,STK33,TEK,TGFBR1,ZAP70 41
kinase-selectivity-class EIF2AK3 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.910 High 1
mh-clint Mouse hepatocyte intrinsic clearance 45.604 High 1
mppb Mouse plasma protein binding (% unbound) 65.370 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 5.495 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 84.420 % High 1
rh-clint Rat hepatocyte intrinsic clearance 82.414 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 85.910 % High 1
rppb Rat plasma protein binding (% unbound) 61.480 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 920.450 uM High 1

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 1588.44 11.31 940 42390 144118 90440999
Toxicity to various agents 679.10 11.31 759 42571 287087 90298030
Cardio-respiratory arrest 385.78 11.31 285 43045 62855 90522262
Drug hypersensitivity 326.97 11.31 698 42632 462911 90122206
Drug abuse 278.33 11.31 264 43066 82083 90503034
Cholecystitis chronic 267.23 11.31 118 43212 9708 90575409
Respiratory arrest 263.07 11.31 176 43154 33135 90551982
Death 163.17 11.31 534 42796 456017 90129100
Cardiac arrest 132.60 11.31 204 43126 104731 90480386
Synovitis 126.07 11.31 8 43322 329744 90255373
Infusion related reaction 120.66 11.31 26 43304 416754 90168363
Hand deformity 120.19 11.31 5 43325 296357 90288760
Intentional product misuse 120.01 11.31 179 43151 89425 90495692
Glossodynia 119.54 11.31 9 43321 321770 90263347
Contraindicated product administered 110.74 11.31 12 43318 320127 90264990
Systemic lupus erythematosus 110.14 11.31 20 43310 361876 90223241
Maternal exposure during pregnancy 109.36 11.31 20 43310 360043 90225074
Depression 101.30 11.31 345 42985 300256 90284861
Drug intolerance 100.73 11.31 44 43286 447547 90137570
Gallbladder disorder 98.13 11.31 79 43251 19724 90565393
Cholelithiasis 96.10 11.31 122 43208 52384 90532733
Wound 96.04 11.31 15 43315 302965 90282152
Lower respiratory tract infection 96.03 11.31 6 43324 250653 90334464
Emotional distress 91.74 11.31 100 43230 36562 90548555
Helicobacter infection 91.38 11.31 4 43326 226846 90358271
Folliculitis 81.02 11.31 4 43326 204349 90380768
Accidental death 80.57 11.31 32 43298 2016 90583101
Treatment failure 80.09 11.31 23 43307 303905 90281212
Anxiety 74.20 11.31 319 43011 309453 90275664
Accidental overdose 74.04 11.31 79 43251 28194 90556923
Hepatic enzyme increased 72.77 11.31 41 43289 360695 90224422
Deep vein thrombosis 68.92 11.31 142 43188 91478 90493639
Drug withdrawal syndrome 67.81 11.31 76 43254 28647 90556470
C-reactive protein increased 67.53 11.31 5 43325 181384 90403733
Joint swelling 67.46 11.31 85 43245 503215 90081902
Biliary dyskinesia 63.60 11.31 29 43301 2570 90582547
Discomfort 61.61 11.31 27 43303 274308 90310809
Arthropathy 61.37 11.31 51 43279 366191 90218926
Back pain 60.04 11.31 305 43025 316870 90268247
Overdose 59.31 11.31 188 43142 157521 90427596
Suspected suicide 57.94 11.31 43 43287 9525 90575592
Inadequate analgesia 57.65 11.31 29 43301 3195 90581922
Liver injury 57.43 11.31 7 43323 170560 90414557
General physical health deterioration 52.94 11.31 55 43275 355060 90230057
Exposure during pregnancy 52.69 11.31 24 43306 238386 90346731
Off label use 51.99 11.31 312 43018 1101940 89483177
Feeling abnormal 51.12 11.31 186 43144 167049 90418068
Type 2 diabetes mellitus 47.23 11.31 19 43311 203225 90381892
Respiratory depression 47.06 11.31 47 43283 15528 90569589
Irritable bowel syndrome 45.65 11.31 21 43309 207427 90377690
Poisoning 44.29 11.31 45 43285 15172 90569945
Sleep disorder due to general medical condition, insomnia type 44.02 11.31 5 43325 128689 90456428
Acute lung injury 44.01 11.31 19 43311 1479 90583638
Swelling 42.63 11.31 85 43245 418973 90166144
Pulmonary embolism 42.11 11.31 148 43182 130672 90454445
Drug dependence 41.27 11.31 60 43270 29267 90555850
Hypersensitivity 40.68 11.31 99 43231 454578 90130539
Ill-defined disorder 40.24 11.31 19 43311 184872 90400245
Impaired healing 39.97 11.31 32 43298 234167 90350950
Abdominal discomfort 38.83 11.31 109 43221 477219 90107898
Wheezing 38.82 11.31 34 43296 238046 90347071
Febrile neutropenia 38.12 11.31 14 43316 158335 90426782
Fall 37.85 11.31 374 42956 481436 90103681
Thrombocytopenia 37.56 11.31 27 43303 208698 90376419
Pyrexia 37.13 11.31 176 43154 660309 89924808
Product use issue 37.02 11.31 63 43267 329856 90255261
Lip dry 36.96 11.31 3 43327 100952 90484165
Metabolic acidosis 35.79 11.31 81 43249 55595 90529522
Psoriatic arthropathy 35.57 11.31 34 43296 228301 90356816
Gallbladder hypofunction 35.42 11.31 12 43318 480 90584637
Therapeutic product effect decreased 34.97 11.31 49 43281 277522 90307595
Product dose omission issue 34.94 11.31 249 43081 291438 90293679
Intervertebral disc protrusion 34.49 11.31 53 43277 27143 90557974
Nausea 33.22 11.31 728 42602 1109588 89475529
Stomatitis 30.31 11.31 53 43277 274645 90310472
Cholecystitis 30.23 11.31 39 43291 17001 90568116
Wound infection 30.01 11.31 7 43323 106395 90478722
Pain in extremity 29.41 11.31 337 42993 450192 90134925
Infection 29.20 11.31 83 43247 362011 90223106
Coagulopathy 27.61 11.31 44 43286 23245 90561872
Respiratory muscle weakness 27.51 11.31 8 43322 192 90584925
Blister 27.41 11.31 50 43280 254948 90330169
Scar 26.94 11.31 35 43295 15360 90569757
Insomnia 26.70 11.31 260 43070 333214 90251903
Rash 26.59 11.31 248 43082 795852 89789265
Red blood cell sedimentation rate increased 26.35 11.31 4 43326 82591 90502526
Coronary artery disease 26.32 11.31 53 43277 33570 90551547
Cerebrovascular accident 25.61 11.31 122 43208 123411 90461706
Musculoskeletal stiffness 25.38 11.31 66 43264 296466 90288651
Tooth disorder 24.33 11.31 49 43281 31041 90554076
Liver disorder 24.11 11.31 14 43316 121255 90463862
Gallbladder injury 24.10 11.31 12 43318 1294 90583823
Epilepsy 24.01 11.31 5 43325 82201 90502916
Joint range of motion decreased 23.81 11.31 18 43312 135625 90449492
Nasopharyngitis 23.71 11.31 107 43223 406997 90178120
Tendon disorder 23.60 11.31 22 43308 6678 90578439
Restless legs syndrome 23.34 11.31 40 43290 22430 90562687
Surgery 23.17 11.31 60 43270 44827 90540290
Inflammation 23.01 11.31 31 43299 178561 90406556
Toxic leukoencephalopathy 22.40 11.31 10 43320 843 90584274
Biliary colic 21.82 11.31 17 43313 4046 90581071
Injection site pain 21.78 11.31 150 43180 173549 90411568
Tremor 21.46 11.31 136 43194 153037 90432080
Hepatitis 21.29 11.31 4 43326 70735 90514382
Constipation 21.17 11.31 216 43114 280179 90304938
Hypercholesterolaemia 20.99 11.31 11 43319 100881 90484236
Peripheral venous disease 20.91 11.31 7 43323 83914 90501203
Chronic kidney disease 20.87 11.31 62 43268 50129 90534988
Exposure via ingestion 20.82 11.31 14 43316 2653 90582464
Drug screen positive 20.79 11.31 16 43314 3741 90581376
Alopecia 20.74 11.31 145 43185 494926 90090191
Withdrawal syndrome 20.69 11.31 38 43292 22486 90562631
Bursitis 20.04 11.31 20 43310 131634 90453483
Blood cholesterol increased 19.61 11.31 44 43286 207968 90377149
Neutropenia 19.28 11.31 50 43280 224854 90360263
Pulmonary fibrosis 19.21 11.31 14 43316 107489 90477628
Prescribed underdose 19.15 11.31 6 43324 75013 90510104
Night sweats 19.10 11.31 20 43310 128746 90456371
Extradural haematoma 18.95 11.31 12 43318 2056 90583061
Thrombosis 18.71 11.31 77 43253 73174 90511943
Tendon pain 18.67 11.31 15 43315 3733 90581384
Drug-induced liver injury 18.57 11.31 10 43320 90308 90494809
Anhedonia 18.48 11.31 25 43305 11406 90573711
Gastrointestinal disorder 18.43 11.31 62 43268 256625 90328492
Sensory disturbance 18.11 11.31 29 43301 15384 90569733
Brain death 17.74 11.31 15 43315 4006 90581111
Mobility decreased 17.71 11.31 61 43269 250673 90334444
Concussion 17.54 11.31 24 43306 11067 90574050
Mental status changes 17.45 11.31 54 43276 44625 90540492
Muscle contractions involuntary 17.37 11.31 13 43317 2915 90582202
Emotional disorder 17.32 11.31 28 43302 14969 90570148
Condition aggravated 17.17 11.31 192 43138 595353 89989764
Hernia 17.02 11.31 27 43303 14204 90570913
Unevaluable event 16.74 11.31 61 43269 54787 90530330
Dysstasia 16.72 11.31 37 43293 25015 90560102
Screaming 16.57 11.31 14 43316 3736 90581381
Plasma cell myeloma 16.56 11.31 50 43280 40778 90544339
Myelosuppression 16.19 11.31 3 43327 53588 90531529
Obesity 16.09 11.31 16 43314 105491 90479626
Bone erosion 15.95 11.31 3 43327 53018 90532099
Bedridden 15.86 11.31 24 43306 12124 90572993
Ankle fracture 15.81 11.31 32 43298 20338 90564779
Expired product administered 15.80 11.31 18 43312 6904 90578213
Blood glucose abnormal 15.71 11.31 21 43309 9471 90575646
Affective disorder 15.68 11.31 19 43311 7774 90577343
Nail growth abnormal 15.63 11.31 7 43323 595 90584522
Brain oedema 15.56 11.31 29 43301 17356 90567761
Nerve compression 15.42 11.31 22 43308 10544 90574573
Grip strength decreased 15.35 11.31 13 43317 92563 90492554
Accidental poisoning 15.33 11.31 8 43322 952 90584165
Coma 15.24 11.31 72 43258 72560 90512557
Intestinal ischaemia 15.24 11.31 20 43310 8863 90576254
Foot fracture 15.23 11.31 37 43293 26569 90558548
Brain herniation 15.20 11.31 14 43316 4186 90580931
Nervousness 15.05 11.31 43 43287 34013 90551104
Toothache 15.02 11.31 33 43297 22197 90562920
Muscle spasms 14.90 11.31 185 43145 251698 90333419
Dehydration 14.76 11.31 150 43180 194297 90390820
Prescribed overdose 14.66 11.31 15 43315 97610 90487507
Decreased interest 14.62 11.31 14 43316 4393 90580724
Nail disorder 14.59 11.31 5 43325 59062 90526055
Nerve injury 14.59 11.31 22 43308 11084 90574033
Muscle atrophy 14.55 11.31 19 43311 8382 90576735
Eye disorder 14.53 11.31 37 43293 27353 90557764
Malabsorption 14.50 11.31 15 43315 5163 90579954
Mental disorder 14.47 11.31 41 43289 32277 90552840
Intervertebral disc degeneration 14.45 11.31 28 43302 17246 90567871
Gait disturbance 14.42 11.31 189 43141 260307 90324810
Abnormal dreams 14.36 11.31 22 43308 11235 90573882
Neuralgia 14.14 11.31 40 43290 31460 90553657
Dry eye 14.09 11.31 60 43270 57871 90527246
Cholesterosis 13.98 11.31 6 43324 460 90584657
Taste disorder 13.89 11.31 6 43324 61540 90523577
Peripheral coldness 13.48 11.31 24 43306 13868 90571249
Bone pain 13.42 11.31 62 43268 61921 90523196
Spinal deformity 13.41 11.31 8 43322 1233 90583884
Spinal cord compression 13.35 11.31 14 43316 4897 90580220
Chronic obstructive pulmonary disease 13.24 11.31 70 43260 73759 90511358
Congenital torticollis 13.04 11.31 3 43327 27 90585090
Crying 12.94 11.31 34 43296 25611 90559506
Lactic acidosis 12.94 11.31 4 43326 50459 90534658
Wrong technique in product usage process 12.93 11.31 68 43262 71503 90513614
Blood potassium decreased 12.85 11.31 51 43279 47676 90537441
Therapy non-responder 12.81 11.31 29 43301 136675 90448442
Muscle tightness 12.76 11.31 23 43307 13416 90571701
Pain 12.74 11.31 590 42740 995751 89589366
Essential tremor 12.46 11.31 8 43322 1404 90583713
Autoimmune disorder 12.45 11.31 11 43319 76733 90508384
Drug ineffective 12.36 11.31 539 42791 1383759 89201358
Lung disorder 12.33 11.31 34 43296 149849 90435268
Myalgia 12.31 11.31 133 43197 174992 90410125
Lupus-like syndrome 12.30 11.31 4 43326 48842 90536275
Substance abuse 12.24 11.31 14 43316 5392 90579725
Lumbar radiculopathy 12.12 11.31 10 43320 2581 90582536
Colitis ulcerative 11.91 11.31 7 43323 60259 90524858
Myocardial infarction 11.82 11.31 89 43241 105883 90479234
Drug abuser 11.80 11.31 10 43320 2680 90582437
Spinal operation 11.72 11.31 19 43311 10177 90574940
Rheumatoid arthritis 11.62 11.31 114 43216 362500 90222617
Hepatotoxicity 11.55 11.31 48 43282 45794 90539323
Leukopenia 11.49 11.31 19 43311 100691 90484426
Septic shock 11.47 11.31 14 43316 84146 90500971
Toxicologic test abnormal 11.40 11.31 6 43324 726 90584391
Gross motor delay 11.38 11.31 4 43326 179 90584938

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 771.20 13.04 543 23228 95922 42501642
Toxicity to various agents 451.07 13.04 594 23177 228542 42369022
Drug abuse 338.55 13.04 351 23420 104420 42493144
Cardio-respiratory arrest 242.43 13.04 225 23546 58411 42539153
Accidental overdose 203.77 13.04 150 23621 28180 42569384
Respiratory arrest 181.14 13.04 140 23631 28284 42569280
Overdose 136.58 13.04 225 23546 105039 42492525
Drug dependence 92.81 13.04 97 23674 28997 42568567
Death 87.59 13.04 503 23268 470682 42126882
Intentional product misuse 79.76 13.04 132 23639 61768 42535796
Cardiac arrest 79.42 13.04 183 23588 109137 42488427
Drug hypersensitivity 70.67 13.04 165 23606 99224 42498340
Off label use 60.35 13.04 171 23600 638164 41959400
Respiratory depression 60.32 13.04 63 23708 18805 42578759
Drug withdrawal syndrome 48.54 13.04 60 23711 21489 42576075
Pyrexia 48.00 13.04 92 23679 393950 42203614
Depression 47.22 13.04 153 23618 111210 42486354
Gun shot wound 44.47 13.04 18 23753 1019 42596545
Inadequate analgesia 42.81 13.04 25 23746 3172 42594392
Drug abuser 40.51 13.04 25 23746 3506 42594058
Insomnia 36.91 13.04 147 23624 118106 42479458
Anxiety 36.70 13.04 147 23624 118413 42479151
General physical health deterioration 31.54 13.04 23 23748 151223 42446341
Poisoning 28.50 13.04 38 23733 14661 42582903
Accidental death 28.37 13.04 19 23752 3064 42594500
Laryngospasm 27.82 13.04 16 23755 1972 42595592
Febrile neutropenia 26.57 13.04 39 23732 185664 42411900
Drug screen positive 25.53 13.04 20 23751 4111 42593453
Neutropenia 24.70 13.04 46 23725 199385 42398179
Environmental exposure 23.96 13.04 8 23763 261 42597303
Myocardial infarction 23.22 13.04 133 23638 123876 42473688
Acute kidney injury 23.06 13.04 116 23655 367221 42230343
Emotional distress 23.00 13.04 36 23735 16057 42581507
Condition aggravated 22.93 13.04 72 23699 260682 42336882
Pain 22.59 13.04 222 23549 244626 42352938
Pulmonary oedema 22.37 13.04 73 23698 53199 42544365
Antasthmatic drug level 21.50 13.04 5 23766 40 42597524
Analgesic drug level 21.18 13.04 5 23766 43 42597521
Ventricular hypertrophy 20.86 13.04 19 23752 4797 42592767
Pulmonary congestion 20.85 13.04 34 23737 15696 42581868
Back disorder 20.36 13.04 23 23748 7491 42590073
Coronary artery disease 20.25 13.04 71 23700 53649 42543915
Renal impairment 20.21 13.04 19 23752 110209 42487355
Road traffic accident 19.75 13.04 37 23734 19056 42578508
Back pain 19.13 13.04 140 23631 141636 42455928
Hepatic function abnormal 18.99 13.04 3 23768 51564 42546000
C-reactive protein increased 18.81 13.04 6 23765 63554 42534010
Substance abuse 18.78 13.04 24 23747 8881 42588683
Multiple organ dysfunction syndrome 18.65 13.04 16 23755 97019 42500545
Cardiomegaly 17.98 13.04 33 23738 16733 42580831
Thrombocytopenia 17.82 13.04 51 23720 190228 42407336
Chest pain 17.82 13.04 136 23635 139394 42458170
Walking disability 17.60 13.04 10 23761 1204 42596360
Rotator cuff syndrome 17.57 13.04 20 23751 6566 42590998
Leukopenia 17.43 13.04 10 23761 74736 42522828
Reaction to excipient 16.98 13.04 8 23763 654 42596910
Feeling abnormal 16.60 13.04 80 23691 69706 42527858
Postictal state 16.42 13.04 9 23762 1011 42596553
Interstitial lung disease 16.26 13.04 12 23759 78450 42519114
Intervertebral disc protrusion 16.14 13.04 25 23746 11047 42586517
Cardiac failure 15.70 13.04 22 23749 106834 42490730
Intentional overdose 15.26 13.04 63 23708 51393 42546171
Poor quality sleep 14.73 13.04 22 23749 9418 42588146
Withdrawal syndrome 14.50 13.04 28 23743 14747 42582817
Gastrooesophageal reflux disease 14.05 13.04 56 23715 44967 42552597
Arteriosclerosis 14.01 13.04 31 23740 17958 42579606
Post-traumatic stress disorder 13.99 13.04 11 23760 2274 42595290
Pain in extremity 13.59 13.04 136 23635 150468 42447096
Suspected suicide 13.54 13.04 17 23754 6182 42591382
Seizure like phenomena 13.18 13.04 8 23763 1089 42596475

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 2706.75 11.37 1588 51239 240793 110295679
Toxicity to various agents 1221.10 11.37 1315 51512 479240 110057232
Cardio-respiratory arrest 759.25 11.37 545 52282 115291 110421181
Drug abuse 645.95 11.37 592 52235 176819 110359653
Respiratory arrest 492.40 11.37 321 52506 57978 110478494
Death 302.81 11.37 873 51954 697996 109838476
Accidental overdose 272.64 11.37 214 52613 51620 110484852
Cardiac arrest 254.09 11.37 386 52441 196367 110340105
Cholecystitis chronic 238.96 11.37 108 52719 9392 110527080
Intentional product misuse 236.16 11.37 304 52523 132600 110403872
Drug hypersensitivity 206.64 11.37 578 52249 453512 110082960
Overdose 185.52 11.37 370 52457 233424 110303048
Accidental death 110.51 11.37 52 52775 4957 110531515
Synovitis 109.75 11.37 5 52822 274087 110262385
Respiratory depression 108.86 11.37 103 52724 31898 110504574
Off label use 101.19 11.37 373 52454 1499812 109036660
Depression 100.79 11.37 357 52470 316978 110219494
Emotional distress 96.41 11.37 113 52714 44734 110491738
Infusion related reaction 96.41 11.37 31 52796 381131 110155341
Maternal exposure during pregnancy 94.89 11.37 7 52820 254876 110281596
Gallbladder disorder 94.02 11.37 79 52748 20950 110515522
Pericarditis 84.56 11.37 5 52822 219109 110317363
Hand deformity 81.33 11.37 6 52821 218500 110317972
C-reactive protein increased 78.29 11.37 7 52820 217912 110318560
Contraindicated product administered 76.96 11.37 13 52814 248254 110288218
Poisoning 75.70 11.37 81 52746 29024 110507448
Glossodynia 74.94 11.37 9 52818 221995 110314477
Lower respiratory tract infection 74.76 11.37 13 52814 243093 110293379
Anxiety 74.22 11.37 344 52483 344734 110191738
Drug intolerance 73.86 11.37 52 52775 406460 110130012
Helicobacter infection 73.85 11.37 3 52824 181874 110354598
Pyrexia 72.40 11.37 206 52621 898059 109638413
Drug withdrawal syndrome 72.19 11.37 90 52737 37964 110498508
Suspected suicide 71.90 11.37 59 52768 15140 110521332
Cholelithiasis 71.45 11.37 117 52710 63305 110473167
Systemic lupus erythematosus 69.22 11.37 18 52809 254320 110282152
Inadequate analgesia 69.00 11.37 38 52789 5039 110531433
Drug dependence 68.54 11.37 101 52726 49919 110486553
General physical health deterioration 64.27 11.37 65 52762 425230 110111242
Folliculitis 64.15 11.37 4 52823 167649 110368823
Treatment failure 61.03 11.37 28 52799 277206 110259266
Biliary dyskinesia 59.23 11.37 27 52800 2394 110534078
Liver injury 56.34 11.37 4 52823 150409 110386063
Hepatic enzyme increased 55.74 11.37 43 52784 320849 110215623
Back pain 55.13 11.37 334 52493 370662 110165810
Feeling abnormal 52.82 11.37 198 52629 180513 110355959
Wound 52.66 11.37 23 52804 234414 110302058
Muscle injury 52.01 11.37 4 52823 140803 110395669
Coronary artery disease 51.50 11.37 109 52718 71581 110464891
Rheumatoid factor positive 50.79 11.37 3 52824 131637 110404835
Febrile neutropenia 49.47 11.37 47 52780 316720 110219752
Drug abuser 48.62 11.37 31 52796 5378 110531094
Hypersensitivity 46.29 11.37 76 52751 403922 110132550
Joint swelling 44.77 11.37 90 52737 442755 110093717
Thrombocytopenia 44.45 11.37 61 52766 348824 110187648
Exposure during pregnancy 43.40 11.37 13 52814 167411 110369061
Gun shot wound 42.45 11.37 17 52810 1095 110535377
Deep vein thrombosis 40.64 11.37 153 52674 139734 110396738
Inflammation 40.26 11.37 21 52806 193217 110343255
Myocardial infarction 40.15 11.37 190 52637 191893 110344579
Neutropenia 37.12 11.37 77 52750 374543 110161929
Lip dry 36.52 11.37 3 52824 100080 110436392
Wheezing 36.30 11.37 41 52786 255189 110281283
Insomnia 35.04 11.37 293 52534 360297 110176175
Gallbladder hypofunction 34.65 11.37 12 52815 514 110535958
Epilepsy 33.96 11.37 4 52823 100205 110436267
Sleep disorder due to general medical condition, insomnia type 33.93 11.37 5 52822 105638 110430834
Liver disorder 33.48 11.37 13 52814 142230 110394242
Drug screen positive 32.68 11.37 26 52801 6384 110530088
Intervertebral disc protrusion 32.42 11.37 52 52775 27646 110508826
Pain in extremity 32.18 11.37 365 52462 486753 110049719
Intentional overdose 32.14 11.37 137 52690 132364 110404108
Stomatitis 31.73 11.37 50 52777 270192 110266280
Myelosuppression 31.39 11.37 4 52823 94336 110442136
Irritable bowel syndrome 31.14 11.37 20 52807 164195 110372277
Acute lung injury 30.68 11.37 19 52808 3132 110533340
Renal impairment 30.54 11.37 27 52800 188418 110348054
Discomfort 29.98 11.37 35 52792 214672 110321800
Type 2 diabetes mellitus 29.20 11.37 25 52802 177207 110359265
Nasopharyngitis 29.12 11.37 94 52733 394267 110142205
Psoriatic arthropathy 27.55 11.37 32 52795 196729 110339743
Impaired healing 26.47 11.37 33 52794 196684 110339788
Mental status changes 26.16 11.37 88 52739 76034 110460438
Substance abuse 26.11 11.37 31 52796 12432 110524040
Coagulopathy 25.75 11.37 59 52768 40852 110495620
Pulmonary congestion 25.70 11.37 50 52777 30916 110505556
Swelling 25.69 11.37 84 52743 350957 110185515
Condition aggravated 25.66 11.37 226 52601 734610 109801862
Drug-induced liver injury 25.08 11.37 13 52814 120054 110416418
Wound infection 24.09 11.37 8 52819 96457 110440015
Product dose omission issue 23.95 11.37 247 52580 321535 110214937
Pulmonary oedema 23.58 11.37 103 52724 100556 110435916
Leukopenia 23.30 11.37 22 52805 148769 110387703
Rotator cuff syndrome 23.13 11.37 34 52793 16760 110519712
Rash 23.06 11.37 266 52561 820698 109715774
Scar 23.00 11.37 34 52793 16847 110519625
Infection 22.97 11.37 92 52735 362108 110174364
Withdrawal syndrome 22.86 11.37 48 52779 31332 110505140
Environmental exposure 22.39 11.37 8 52819 376 110536096
Antasthmatic drug level 22.27 11.37 5 52822 40 110536432
Pain 22.21 11.37 605 52222 954350 109582122
Brain oedema 22 11.37 47 52780 31051 110505421
Hernia 21.99 11.37 36 52791 19464 110517008
Cardiac failure 21.74 11.37 35 52792 187591 110348881
Analgesic drug level 21.74 11.37 5 52822 45 110536427
Respiratory muscle weakness 21.69 11.37 8 52819 412 110536060
Interstitial lung disease 21.35 11.37 21 52806 139313 110397159
Gallbladder injury 21.34 11.37 11 52816 1277 110535195
Hepatic function abnormal 21.28 11.37 8 52819 89287 110447185
Restless legs syndrome 20.73 11.37 40 52787 24586 110511886
Rash maculo-papular 20.67 11.37 5 52822 74217 110462255
Drug reaction with eosinophilia and systemic symptoms 20.16 11.37 7 52820 82088 110454384
Cerebrovascular accident 20.16 11.37 152 52675 181132 110355340
Surgery 20.13 11.37 54 52773 41229 110495243
Laryngospasm 19.76 11.37 17 52810 4651 110531821
Product use in unapproved indication 19.66 11.37 129 52698 447248 110089224
Fall 19.41 11.37 400 52427 603082 109933390
Drug ineffective 19.16 11.37 567 52260 1519973 109016499
Ventricular hypertrophy 19.01 11.37 20 52807 7025 110529447
Prescribed underdose 18.93 11.37 4 52823 65170 110471302
Arthropathy 18.89 11.37 72 52755 287450 110249022
Multiple organ dysfunction syndrome 18.83 11.37 27 52800 151683 110384789
Red blood cell sedimentation rate increased 18.68 11.37 7 52820 78295 110458177
Product use issue 18.63 11.37 81 52746 311614 110224858
Opiates positive 18.44 11.37 9 52818 930 110535542
Hepatitis 18.44 11.37 10 52817 90044 110446428
Cardiomegaly 18.32 11.37 42 52785 29088 110507384
Hyperkalaemia 18.04 11.37 23 52804 135773 110400699
Tendon disorder 17.90 11.37 21 52806 8316 110528156
Extradural haematoma 17.90 11.37 14 52813 3355 110533117
Urticaria 17.78 11.37 85 52742 318772 110217700
Coronary artery stenosis 17.73 11.37 27 52800 13731 110522741
Therapeutic product effect decreased 17.49 11.37 59 52768 244257 110292215
Ill-defined disorder 17.49 11.37 30 52797 156823 110379649
Hyponatraemia 17.39 11.37 50 52777 217603 110318869
Bursitis 17.26 11.37 22 52805 129896 110406576
Exposure via ingestion 17.10 11.37 16 52811 4884 110531588
Chronic kidney disease 17.06 11.37 77 52750 76214 110460258
Impaired driving ability 17.04 11.37 18 52809 6352 110530120
Arteriosclerosis 17.03 11.37 37 52790 24730 110511742
Metabolic acidosis 16.86 11.37 93 52734 99651 110436821
Head injury 16.84 11.37 52 52775 42965 110493507
Bedridden 16.81 11.37 26 52801 13399 110523073
Lactic acidosis 16.66 11.37 12 52815 92799 110443673
Fatigue 16.54 11.37 724 52103 1215234 109321238
Night sweats 16.48 11.37 24 52803 133959 110402513
Back disorder 16.42 11.37 33 52794 20889 110515583
Toxic leukoencephalopathy 16.38 11.37 10 52817 1607 110534865
Peripheral venous disease 16.28 11.37 10 52817 84107 110452365
Pulmonary fibrosis 16.08 11.37 15 52812 102027 110434445
Eosinophilia 15.94 11.37 4 52823 57932 110478540
Blood pressure systolic increased 15.88 11.37 10 52817 82981 110453491
Pulmonary embolism 15.65 11.37 164 52663 214310 110322162
Gastrointestinal disorder 15.62 11.37 61 52766 241891 110294581
Blister 15.54 11.37 56 52771 227320 110309152
Colitis ulcerative 15.25 11.37 9 52818 77354 110459118
Nerve injury 15.21 11.37 22 52805 10691 110525781
Acute kidney injury 15.17 11.37 213 52614 635217 109901255
Copper deficiency 15.06 11.37 5 52822 188 110536284
Cholecystectomy 15.05 11.37 22 52805 10787 110525685
Chest pain 15.03 11.37 258 52569 376117 110160355
Multiple injuries 14.97 11.37 13 52814 3601 110532871
Angioedema 14.91 11.37 15 52812 98485 110437987
Brain death 14.86 11.37 17 52810 6556 110529916
Cholecystitis 14.85 11.37 36 52791 25846 110510626
Joint range of motion decreased 14.81 11.37 22 52805 121810 110414662
Intervertebral disc degeneration 14.76 11.37 29 52798 18056 110518416
Lung disorder 14.65 11.37 41 52786 180006 110356466
Mobility decreased 14.61 11.37 61 52766 237361 110299111
Spinal cord compression 14.54 11.37 18 52809 7534 110528938
Walking disability 14.51 11.37 11 52816 2517 110533955
Lumbar radiculopathy 14.32 11.37 11 52816 2567 110533905
Mucosal inflammation 14.15 11.37 15 52812 96126 110440346
Biliary colic 14.13 11.37 14 52813 4583 110531889
Pancytopenia 14.08 11.37 52 52775 209561 110326911
Coronary artery occlusion 13.74 11.37 26 52801 15746 110520726
Tendon pain 13.69 11.37 16 52811 6310 110530162
Musculoskeletal stiffness 13.68 11.37 78 52749 279744 110256728
Drug use disorder 13.58 11.37 28 52799 18046 110518426
Chronic obstructive pulmonary disease 13.55 11.37 94 52733 109064 110427408
Drug resistance 13.52 11.37 5 52822 56369 110480103
Neuropathy peripheral 13.51 11.37 138 52689 179139 110357333
Malabsorption 13.49 11.37 16 52811 6409 110530063
Blood glucose abnormal 13.44 11.37 23 52804 12893 110523579
Acute myocardial infarction 13.43 11.37 77 52750 83700 110452772
Therapy non-responder 13.42 11.37 35 52792 157272 110379200
Decreased interest 13.36 11.37 14 52813 4894 110531578
Therapeutic product effect increased 13.34 11.37 9 52818 1716 110534756
Emotional disorder 13.30 11.37 26 52801 16134 110520338
Obesity 13.27 11.37 21 52806 113330 110423142
Accidental exposure to product 13.13 11.37 53 52774 49955 110486517
Frequent bowel movements 13.12 11.37 9 52818 71381 110465091
Sensory disturbance 13.09 11.37 27 52800 17402 110519070
Peripheral coldness 13.09 11.37 28 52799 18512 110517960
Nail growth abnormal 13.09 11.37 6 52821 539 110535933
Obstructive airways disorder 13.07 11.37 3 52824 46146 110490326
Muscle strain 13.07 11.37 21 52806 11181 110525291
Toxicologic test abnormal 13.03 11.37 8 52819 1299 110535173
Dry skin 12.95 11.37 92 52735 107561 110428911
Product adhesion issue 12.83 11.37 11 52816 2995 110533477
Erythema 12.81 11.37 84 52743 291363 110245109
Mitral valve incompetence 12.78 11.37 40 52787 33289 110503183
Pleural adhesion 12.70 11.37 5 52822 308 110536164
Muscle contractions involuntary 12.68 11.37 13 52814 4431 110532041
Spinal osteoarthritis 12.58 11.37 29 52798 20154 110516318
Thrombosis 12.58 11.37 92 52735 108570 110427902
Nail disorder 12.51 11.37 6 52821 57929 110478543
Accidental poisoning 12.49 11.37 10 52817 2477 110533995
Carpal tunnel syndrome 12.49 11.37 31 52796 22579 110513893
Altered state of consciousness 12.39 11.37 6 52821 57620 110478852
Neck injury 12.33 11.37 11 52816 3157 110533315
Nausea 12.29 11.37 714 52113 1234976 109301496
Plasma cell myeloma 12.23 11.37 61 52766 62875 110473597
Exposure to toxic agent 12.21 11.37 22 52805 12836 110523636
Injury 12.21 11.37 134 52693 177131 110359341
Nervousness 12.13 11.37 42 52785 36809 110499663
Intestinal ischaemia 12.08 11.37 25 52802 16154 110520318
Gallbladder cholesterolosis 12.07 11.37 6 52821 645 110535827
Accident 12.05 11.37 20 52807 10932 110525540
Intervertebral disc disorder 12.03 11.37 14 52813 5498 110530974
Neutrophil count decreased 11.84 11.37 25 52802 120916 110415556
Joint injury 11.82 11.37 44 52783 39950 110496522
Nerve compression 11.81 11.37 20 52807 11117 110525355
Liver function test increased 11.76 11.37 15 52812 88533 110447939
Muscle atrophy 11.74 11.37 22 52805 13232 110523240
Cholesterosis 11.72 11.37 5 52822 378 110536094
Affective disorder 11.67 11.37 20 52807 11221 110525251
Anaphylactic shock 11.66 11.37 5 52822 51541 110484931
COVID-19 11.61 11.37 69 52758 244991 110291481
Rib fracture 11.57 11.37 39 52788 33731 110502741
Post concussion syndrome 11.55 11.37 6 52821 707 110535765
Pregnancy 11.47 11.37 5 52822 51062 110485410
Spinal stenosis 11.46 11.37 27 52800 19029 110517443
Memory impairment 11.40 11.37 144 52683 196800 110339672

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N02AJ22 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ23 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
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 D002492 Central Nervous System Depressants
MeSH PA D009294 Narcotics
MeSH PA D018689 Sensory System Agents
MeSH PA D019141 Respiratory System Agents
CHEBI has role CHEBI:35482 opioid analgesic
CHEBI has role CHEBI:51177 antitussive
CHEBI has role CHEBI:55322 ฮผ-opioid receptor agonist
FDA EPC N0000175690 Opioid Agonist

Related Drugs by ATC class:

N02AJ Opioids in combination with non-opioid analgesics 9 drugs
acetylsalicylic acidcelecoxibcodeinedexketoprofendihydrocodeineibuprofenoxycodoneparacetamoltramadol
R05DA Opium alkaloids and derivatives 10 drugs
acetyldihydrocodeinecodeinedextromethorphandimemorfanethylmorphinemorphinenormethadonenoscapinepholcodinethebacon

Drug Use | Suggest Off label Use Form| |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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA N206627 Nov. 20, 2014 DISCN 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 KNOA PHARMA N206627 Nov. 20, 2014 DISCN 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 KNOA PHARMA N206627 Nov. 20, 2014 DISCN 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 KNOA PHARMA N206627 Nov. 20, 2014 DISCN 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 KNOA PHARMA N206627 Nov. 20, 2014 DISCN 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA N206627 Nov. 20, 2014 DISCN 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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 KNOA PHARMA 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
CHEMBL3989677 ChEMBL_ID
DB00956 DRUGBANK_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 0054-0843 LIQUID 10 mg ORAL ANDA 31 sections
Hydrocodone Bitartrate and Homatropine Methylbromide HUMAN PRESCRIPTION DRUG LABEL 2 0121-1036 SOLUTION 5 mg ORAL NDA authorized generic 29 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0121-1544 SOLUTION 5 mg ORAL ANDA 29 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0121-2316 SOLUTION 7.50 mg ORAL ANDA 29 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0121-4772 SOLUTION 2.50 mg ORAL ANDA 29 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 0245-0412 TABLET 10 mg ORAL ANDA 37 sections
HYDROCODONE BITARTRATE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 0406-0123 TABLET 5 mg ORAL ANDA 25 sections
HYDROCODONE BITARTRATE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 0406-0124 TABLET 7.50 mg ORAL ANDA 25 sections
HYDROCODONE BITARTRATE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 0406-0125 TABLET 10 mg ORAL ANDA 25 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0406-0376 TABLET 5 mg ORAL ANDA 25 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0406-0377 TABLET 7.50 mg ORAL ANDA 25 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0406-0378 TABLET 10 mg ORAL ANDA 25 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
Hydrocodone Bitartrate and Homatropine Methylbromide HUMAN PRESCRIPTION DRUG LABEL 2 10702-055 TABLET 5 mg ORAL ANDA 19 sections
Hydrocodone Bitartrate and Homatropine Methylbromide HUMAN PRESCRIPTION DRUG LABEL 2 10702-150 LIQUID 5 mg ORAL ANDA 20 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 10702-189 TABLET 5 mg ORAL ANDA 24 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 10702-190 TABLET 7.50 mg ORAL ANDA 24 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 10702-191 TABLET 10 mg ORAL ANDA 24 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 10702-192 TABLET 5 mg ORAL ANDA 24 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 10702-193 TABLET 7.50 mg ORAL ANDA 24 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 10702-194 TABLET 10 mg ORAL ANDA 24 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 12634-144 TABLET 10 mg ORAL ANDA 25 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 12634-256 TABLET 10 mg ORAL ANDA 25 sections
HYDROCODONE BITARTRATE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 12634-260 TABLET 7.50 mg ORAL ANDA 25 sections
HYDROCODONE BITARTRATE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 12634-264 TABLET 5 mg ORAL ANDA 27 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 12634-616 SOLUTION 7.50 mg ORAL ANDA 13 sections