hydrocodone indications/contra

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

Drug dosage:

DoseUnitRoute
15 mg O

Approvals:

DateAgencyCompanyOrphan
March 23, 1943 FDA ENDO PHARMS

FDA Adverse Event Reporting System

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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 5629.85 28.03 1372 5449 29742 3349296
Drug hypersensitivity 3646.46 28.03 1005 5816 34675 3344363
Toxicity to various agents 2329.66 28.03 761 6060 46293 3332745
Drug abuse 2252.13 28.03 601 6220 17729 3361309
Respiratory arrest 1701.10 28.03 437 6384 10931 3368107
Cardio-respiratory arrest 1458.48 28.03 413 6408 15027 3364011
Cardiac arrest 1411.91 28.03 459 6362 26860 3352178
Overdose 1160.58 28.03 419 6402 33559 3345479
Death 847.33 28.03 536 6285 151788 3227250
Accidental overdose 717.44 28.03 201 6620 6917 3372121
Intentional product misuse 655.03 28.03 214 6607 12487 3366551
Intentional overdose 429.64 28.03 164 6657 15061 3363977
Poisoning 388.26 28.03 116 6705 4996 3374042
Drug ineffective 357.76 28.03 287 6534 115803 3263235
Drug dependence 352.75 28.03 104 6717 4272 3374766
Nausea 329.98 28.03 287 6534 129358 3249680
Vomiting 320.19 28.03 242 6579 89289 3289749
Pain 306.87 28.03 216 6605 71341 3307697
Constipation 284.27 28.03 152 6669 30660 3348378
Somnolence 266.91 28.03 148 6673 32056 3346982
Drug abuser 247.67 28.03 71 6750 2632 3376406
Mental status changes 235.49 28.03 95 6726 10052 3368986
Drug screen positive 191.73 28.03 54 6767 1874 3377164
Confusional state 165.28 28.03 116 6705 37882 3341156
Drug withdrawal syndrome 157.97 28.03 75 6746 11710 3367328
Accidental death 152.80 28.03 36 6785 602 3378436
Substance abuse 149.14 28.03 40 6781 1152 3377886
Unresponsive to stimuli 145.44 28.03 63 6758 7945 3371093
Abdominal pain 142.84 28.03 115 6706 46110 3332928
Coma 138.64 28.03 70 6751 12482 3366556

Pharmacologic Action:

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SourceCodeDescription
ATC R05DA03 RESPIRATORY SYSTEM
COUGH AND COLD PREPARATIONS
COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
Opium alkaloids and derivatives
FDA EPC N0000175690 Opioid Agonist
FDA MoA N0000000174 Opioid Agonists
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
CHEBI has role CHEBI:55322 mu-opioid receptor agonist
CHEBI has role CHEBI:35482 opioid analgesic
CHEBI has role CHEBI:51177 antitussive
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

Drug Use (View source of the data)

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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 DOID:13976
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 DOID:2349
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:2527
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 DOID:1826
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 DOID:3122
Benign prostatic hyperplasia contraindication 266569009 DOID:2883
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 DOID:13774
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

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.64 Basic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG HYSINGLA PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9060940 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9675611 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9682077 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9060940 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9675611 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9682077 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9060940 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9675611 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9682077 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9060940 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9675611 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9682077 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9060940 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9675611 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9682077 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9060940 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9675611 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9682077 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9060940 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9675611 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 9682077 Oct. 30, 2020 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 6733783 Oct. 30, 2021 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 6733783 Oct. 30, 2021 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 6733783 Oct. 30, 2021 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 6733783 Oct. 30, 2021 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 6733783 Oct. 30, 2021 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 6733783 Oct. 30, 2021 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 PURDUE PHARMA LP N206627 Nov. 20, 2014 RX TABLET, EXTENDED RELEASE ORAL 6733783 Oct. 30, 2021 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9265760 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
10MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9326982 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
10MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9333201 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
10MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9339499 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
10MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9421200 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
10MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9433619 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
10MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9610286 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
15MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9265760 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
15MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9326982 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
15MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9333201 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
15MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9339499 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
15MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9421200 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
15MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9433619 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
15MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9610286 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
20MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9265760 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
20MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9326982 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
20MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9333201 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
20MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9339499 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
20MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9421200 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
20MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9433619 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
20MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9610286 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
30MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9265760 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
30MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9326982 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
30MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9333201 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
30MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9339499 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
30MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9421200 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
30MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9433619 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
30MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9610286 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
40MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9265760 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
40MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9326982 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
40MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9333201 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
40MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9339499 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
40MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9421200 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
40MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9433619 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
40MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9610286 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
50MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9265760 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
50MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9326982 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
50MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9333201 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
50MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9339499 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
50MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9421200 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
50MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9433619 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
50MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9610286 July 25, 2033 TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
10MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9452163 Sept. 12, 2034 TREATMENT OF PAIN
10MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9486451 Sept. 12, 2034 TREATMENT OF PAIN
10MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9713611 Sept. 12, 2034 TREATMENT OF PAIN
15MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9452163 Sept. 12, 2034 TREATMENT OF PAIN
15MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9486451 Sept. 12, 2034 TREATMENT OF PAIN
15MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9713611 Sept. 12, 2034 TREATMENT OF PAIN
20MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9452163 Sept. 12, 2034 TREATMENT OF PAIN
20MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9486451 Sept. 12, 2034 TREATMENT OF PAIN
20MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9713611 Sept. 12, 2034 TREATMENT OF PAIN
30MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9452163 Sept. 12, 2034 TREATMENT OF PAIN
30MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9486451 Sept. 12, 2034 TREATMENT OF PAIN
30MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9713611 Sept. 12, 2034 TREATMENT OF PAIN
40MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9452163 Sept. 12, 2034 TREATMENT OF PAIN
40MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9486451 Sept. 12, 2034 TREATMENT OF PAIN
40MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9713611 Sept. 12, 2034 TREATMENT OF PAIN
50MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9452163 Sept. 12, 2034 TREATMENT OF PAIN
50MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9486451 Sept. 12, 2034 TREATMENT OF PAIN
50MG ZOHYDRO ER PERNIX IRELAND PAIN N202880 Oct. 25, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9713611 Sept. 12, 2034 TREATMENT OF PAIN
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

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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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:

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IDSource
4018165 VUID
N0000146502 NUI
C0020264 UMLSCUI
7081 IUPHAR_LIGAND_ID
D03725 KEGG_DRUG
6YKS4Y3WQ7 UNII
1700 INN_ID
DB00956 DRUGBANK_ID
5284569 PUBCHEM_CID
5489 RXNORM
20320002 SNOMEDCT_US
372671002 SNOMEDCT_US
4018165 VANDF
N0000006456 NDFRT
N0000146502 NDFRT
d03075 MMSL
001554 NDDF
CHEMBL1457 ChEMBL_ID
CHEBI:5779 CHEBI
CHEMBL1201470 ChEMBL_ID
D006853 MESH_DESCRIPTOR_UI
CHEMBL2062267 ChEMBL_ID
34195-34-1 SECONDARY_CAS_RN

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
Norco HUMAN PRESCRIPTION DRUG LABEL 2 0023-6002 TABLET 5 mg ORAL ANDA 14 sections
Norco HUMAN PRESCRIPTION DRUG LABEL 2 0023-6021 TABLET 7.50 mg ORAL ANDA 14 sections
Norco HUMAN PRESCRIPTION DRUG LABEL 2 0023-6022 TABLET 10 mg ORAL ANDA 14 sections
Vicodin HUMAN PRESCRIPTION DRUG LABEL 2 0074-3041 TABLET 5 mg ORAL ANDA 14 sections
Vicodin HUMAN PRESCRIPTION DRUG LABEL 2 0074-3043 TABLET 7.50 mg ORAL ANDA 14 sections
Vicodin HUMAN PRESCRIPTION DRUG LABEL 2 0074-3054 TABLET 10 mg ORAL ANDA 14 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0121-0772 SOLUTION 7.50 mg ORAL ANDA 16 sections
Zamicet HUMAN PRESCRIPTION DRUG LABEL 2 0121-1542 SOLUTION 5 mg ORAL ANDA 15 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0121-1544 SOLUTION 7.50 mg ORAL ANDA 16 sections
Zamicet HUMAN PRESCRIPTION DRUG LABEL 2 0121-2313 SOLUTION 10 mg ORAL ANDA 15 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0121-2316 SOLUTION 7.50 mg ORAL ANDA 16 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0121-4771 SOLUTION 5 mg ORAL ANDA 15 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0121-4772 SOLUTION 7.50 mg ORAL ANDA 16 sections
Hydrocodone Bitartrate and Homatropine Methylbromide HUMAN PRESCRIPTION DRUG LABEL 2 0121-4811 SYRUP 5 mg ORAL ANDA 15 sections
HYCOFENIX HUMAN PRESCRIPTION DRUG LABEL 3 0178-3291 LIQUID 2.50 mg ORAL NDA 19 sections
Flowtuss HUMAN PRESCRIPTION DRUG LABEL 2 0178-3482 LIQUID 2.50 mg ORAL NDA 19 sections
TussiCaps HUMAN PRESCRIPTION DRUG LABEL 2 0187-0054 CAPSULE, EXTENDED RELEASE 5 mg ORAL ANDA 14 sections
TussiCaps HUMAN PRESCRIPTION DRUG LABEL 2 0187-0108 CAPSULE, EXTENDED RELEASE 10 mg ORAL ANDA 14 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0245-0410 TABLET 5 mg ORAL ANDA 15 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0245-0411 TABLET 7.50 mg ORAL ANDA 15 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0245-0412 TABLET 10 mg ORAL ANDA 15 sections
HYDROCODONE BITARTRATE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 0406-0123 TABLET 5 mg ORAL ANDA 14 sections
HYDROCODONE BITARTRATE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 0406-0124 TABLET 7.50 mg ORAL ANDA 14 sections
HYDROCODONE BITARTRATE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 0406-0125 TABLET 10 mg ORAL ANDA 14 sections
HYDROCODONE BITARTRATE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 0406-0357 TABLET 5 mg ORAL ANDA 14 sections
HYDROCODONE BITARTRATE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 0406-0358 TABLET 7.50 mg ORAL ANDA 14 sections
HYDROCODONE BITARTRATE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 0406-0365 TABLET 5 mg ORAL ANDA 14 sections
HYDROCODONE BITARTRATE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 0406-0366 TABLET 7.50 mg ORAL ANDA 14 sections
HYDROCODONE BITARTRATE AND ACETAMINOPHEN HUMAN PRESCRIPTION DRUG LABEL 2 0406-0367 TABLET 10 mg ORAL ANDA 14 sections
Hydrocodone Bitartrate and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0406-0376 TABLET 5 mg ORAL ANDA 14 sections