oxycodone indications/contra

Stem definitionDrug idCAS RN
2029 76-42-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • oxycontin
  • oxycodone
  • dihydro-14-hydroxycodeinone
  • dihydrohydroxycodeinone
  • dihydrone
  • oxicon
  • oxycodeinone
  • oxymorphone 3-methyl ether
  • oxynorm
  • oxycodone hydrochloride
  • oxycodone terephthalate
  • oxycodone hydrochloride hydrate
  • oxycodone HCl
A semisynthetic derivative of CODEINE.
  • Molecular weight: 315.37
  • Formula: C18H21NO4
  • CLOGP: -0.04
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 59
  • ALOGS: -1.75
  • ROTB: 1

Drug dosage:

DoseUnitRoute
75 mg O
30 mg P
75 mg O

Approvals:

DateAgencyCompanyOrphan
April 12, 1950 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
Drug abuse 9328.07 28.69 2321 17995 16009 3349534
Completed suicide 7590.81 28.69 2206 18110 28908 3336635
Drug abuser 7372.13 28.69 1371 18945 1332 3364211
Toxicity to various agents 6378.98 28.69 2129 18187 44925 3320618
Overdose 5736.76 28.69 1819 18497 32159 3333384
Drug dependence 5097.11 28.69 1093 19223 3283 3362260
Respiratory arrest 4848.19 28.69 1257 19059 10111 3355432
Cardiac arrest 3715.47 28.69 1246 19070 26073 3339470
Death 3427.46 28.69 1938 18378 150386 3215157
Cardio-respiratory arrest 3299.38 28.69 995 19321 14445 3351098
Accidental overdose 3270.55 28.69 837 19479 6281 3359262
Drug withdrawal syndrome 2607.20 28.69 781 19535 11004 3354539
Intentional product misuse 2166.72 28.69 690 19626 12011 3353532
Drug hypersensitivity 2143.12 28.69 896 19420 34784 3330759
Somnolence 2028.65 28.69 837 19479 31367 3334176
Substance abuse 1999.99 28.69 404 19912 788 3364755
Poisoning 1919.74 28.69 513 19803 4599 3360944
Inadequate analgesia 1706.24 28.69 357 19959 892 3364651
Pain 1639.44 28.69 929 19387 70628 3294915
Constipation 1334.34 28.69 616 19700 30196 3335347
Coma 1271.87 28.69 462 19854 12090 3353453
Vomiting 1260.41 28.69 853 19463 88678 3276865
Nausea 1175.49 28.69 947 19369 128698 3236845
Confusional state 1144.58 28.69 593 19723 37405 3328138
Intentional overdose 1139.09 28.69 449 19867 14776 3350767
Respiratory depression 984.71 28.69 286 20030 3548 3361995
Delirium 969.54 28.69 353 19963 9275 3356268
Drug ineffective 894.17 28.69 773 19543 115317 3250226
Depression 878.74 28.69 506 19810 39264 3326279
Depressed level of consciousness 790.32 28.69 319 19997 11146 3354397

Pharmacologic Action:

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SourceCodeDescription
ATC N02AA05 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AA55 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AA56 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N02AJ17 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ18 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ19 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
CHEBI has role CHEBI:35482 opioid analgesic
CHEBI has role CHEBI:55322 mu-opioid receptor agonist
CHEBI has role CHEBI:51177 antitussive
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 D018689 Sensory System Agents
FDA MoA N0000175684 Full Opioid Agonists
FDA EPC N0000175690 Opioid Agonist

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Severe pain indication 76948002
Acute postoperative pain indication 107401000119105
Chronic Pain with Opioid Tolerance indication
Hypophosphatemia contraindication 4996001
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Alcoholism contraindication 7200002
Alcohol withdrawal delirium contraindication 8635005
Asthenia contraindication 13791008
Constipation contraindication 14760008 DOID:2089
Mood swings contraindication 18963009
Myocardial infarction contraindication 22298006 DOID:5844
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Hypercapnia contraindication 29596007
Dehydration contraindication 34095006
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Gastrointestinal ulcer contraindication 40845000
Hypothyroidism contraindication 40930008 DOID:1459
Fecal impaction contraindication 44635007
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Gastrointestinal perforation contraindication 51875005
Vitamin K deficiency contraindication 52675005 DOID:11249
Nasal polyp contraindication 52756005
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Diarrhea contraindication 62315008
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Hemorrhoids contraindication 70153002 DOID:9746
Poisoning by acetaminophen contraindication 70273001
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
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Cor pulmonale contraindication 83291003 DOID:8515
Pulmonary emphysema contraindication 87433001
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:2527
Hemophilia contraindication 90935002
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
Drug-induced psychosis contraindication 191483003 DOID:1742
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Chronic diarrhea contraindication 236071009
Aluminum intoxication contraindication 236546003
Morbid obesity contraindication 238136002 DOID:11981
Benign prostatic hyperplasia contraindication 266569009 DOID:2883
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Exacerbation of asthma contraindication 281239006
Pregnancy, function contraindication 289908002
Lesion of brain contraindication 301766008
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Skin irritation contraindication 367466007
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000 DOID:13774
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Cardiovascular event risk contraindication 395112001
Breastfeeding (mother) contraindication 413712001
Central nervous system depression contraindication 418072004
Dysfunction of sphincter of Oddi contraindication 430887001
Acute erosive gastritis contraindication 444926003
Smokes tobacco daily contraindication 449868002
Acute Thromboembolic Stroke contraindication
Neuropathic pain off-label use 247398009

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.97 Basic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9205082 Dec. 22, 2018 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9474750 Dec. 22, 2018 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9205082 Dec. 22, 2018 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9474750 Dec. 22, 2018 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9205082 Dec. 22, 2018 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9474750 Dec. 22, 2018 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8969369 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9056051 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9084729 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9161937 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9168252 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283216 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283221 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9345701 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9511066 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE BY PROVIDING AN ABUSE-DETERRENT ORAL CONTROLLED RELEASE COMBINATION DRUG PRODUCT
20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8969369 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9056051 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9084729 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9161937 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9168252 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283216 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283221 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9345701 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9511066 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE BY PROVIDING AN ABUSE-DETERRENT ORAL CONTROLLED RELEASE COMBINATION DRUG PRODUCT
40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8969369 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9056051 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9084729 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9161937 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9168252 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283216 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9283221 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9345701 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
40MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9511066 May 10, 2022 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE BY PROVIDING AN ABUSE-DETERRENT ORAL CONTROLLED RELEASE COMBINATION DRUG PRODUCT
10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9555000 April 4, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
10MG TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9907793 April 4, 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 TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9555000 April 4, 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 TARGINIQ PURDUE PHARMA LP N205777 July 23, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9907793 April 4, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8840928 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9248195 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8840928 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9248195 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8840928 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9248195 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8840928 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9248195 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8840928 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9248195 July 7, 2023 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
10MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 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.
15MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 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.
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8758813 June 10, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8758813 June 10, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8758813 June 10, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8758813 June 10, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8758813 June 10, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
10MG TROXYCA ER PFIZER INC N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
20MG TROXYCA ER PFIZER INC N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
30MG TROXYCA ER PFIZER INC N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
40MG TROXYCA ER PFIZER INC N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
60MG TROXYCA ER PFIZER INC N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
80MG TROXYCA ER PFIZER INC N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 7976870 June 1, 2027 METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM
10MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8808741 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.
10MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 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.
10MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492393 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.
15MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8808741 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.
15MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 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.
15MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492393 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8808741 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492393 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8808741 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492393 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8808741 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492393 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8808741 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492393 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 8808741 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 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 OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL 9492393 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.
7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8372432 March 11, 2029 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8668929 March 11, 2029 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8377453 Nov. 19, 2029 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9682075 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9682075 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9682075 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9682075 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9682075 Dec. 10, 2030 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8741885 May 16, 2032 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9468636 May 16, 2032 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9737530 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9737530 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9737530 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9737530 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 9737530 Sept. 2, 2036 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.

Orange Book exclusivity data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL Aug. 13, 2018 NEW PATIENT POPULATION
15MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL Aug. 13, 2018 NEW PATIENT POPULATION
20MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL Aug. 13, 2018 NEW PATIENT POPULATION
30MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL Aug. 13, 2018 NEW PATIENT POPULATION
40MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL Aug. 13, 2018 NEW PATIENT POPULATION
60MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL Aug. 13, 2018 NEW PATIENT POPULATION
80MG OXYCONTIN PURDUE PHARMA LP N022272 April 5, 2010 RX TABLET, EXTENDED RELEASE ORAL Aug. 13, 2018 NEW PATIENT POPULATION
13.5MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL April 26, 2019 NEW PRODUCT
18MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL April 26, 2019 NEW PRODUCT
27MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL April 26, 2019 NEW PRODUCT
36MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL April 26, 2019 NEW PRODUCT
9MG XTAMPZA ER COLLEGIUM PHARM INC N208090 April 26, 2016 RX CAPSULE, EXTENDED RELEASE ORAL April 26, 2019 NEW PRODUCT
10MG TROXYCA ER PFIZER INC N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL Aug. 19, 2019 NEW COMBINATION
20MG TROXYCA ER PFIZER INC N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL Aug. 19, 2019 NEW COMBINATION
30MG TROXYCA ER PFIZER INC N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL Aug. 19, 2019 NEW COMBINATION
40MG TROXYCA ER PFIZER INC N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL Aug. 19, 2019 NEW COMBINATION
60MG TROXYCA ER PFIZER INC N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL Aug. 19, 2019 NEW COMBINATION
80MG TROXYCA ER PFIZER INC N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL Aug. 19, 2019 NEW COMBINATION

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Mu-type opioid receptor GPCR AGONIST Ki 7.80 WOMBAT-PK CHEMBL
Kappa-type opioid receptor GPCR EC50 4.80 CHEMBL
Delta-type opioid receptor GPCR EC50 5.40 CHEMBL
Acetylcholinesterase Enzyme IC50 4.12 CHEMBL
Kappa-type opioid receptor GPCR EC50 4.80 CHEMBL
Kappa-type opioid receptor GPCR Ki 5.58 CHEMBL
Delta-type opioid receptor GPCR Ki 5.96 CHEMBL
Mu-type opioid receptor GPCR Ki 7.36 CHEMBL
Mu-type opioid receptor GPCR EC50 6.80 CHEMBL

External reference:

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IDSource
DB00497 DRUGBANK_ID
C0722364 UMLSCUI
7093 IUPHAR_LIGAND_ID
D00847 KEGG_DRUG
CHEMBL656 ChEMBL_ID
414984009 SNOMEDCT_US
4019870 VANDF
7804 RXNORM
55452001 SNOMEDCT_US
N0000005712 NDFRT
N0000147955 NDFRT
d00329 MMSL
001558 NDDF
31648 MMSL
5284603 PUBCHEM_CID
CHEMBL1200611 ChEMBL_ID
CHEMBL1200890 ChEMBL_ID
C016026 MESH_SUPPLEMENTAL_RECORD_UI
C1ENJ2TE6C UNII
124-90-3 SECONDARY_CAS_RN
1701 INN_ID
D010098 MESH_DESCRIPTOR_UI
CHEBI:7852 CHEBI

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
oxycodone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0390 SOLUTION 5 mg ORAL ANDA 18 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0393 SOLUTION 100 mg ORAL ANDA 18 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0522 SOLUTION 100 mg ORAL ANDA 18 sections
Oxycodone and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0054-0551 TABLET 5 mg ORAL ANDA 14 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-3686 SOLUTION 5 mg ORAL ANDA 13 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-4650 TABLET 5 mg ORAL ANDA 13 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-8648 SOLUTION 5 mg ORAL ANDA 13 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-8650 TABLET 5 mg ORAL ANDA 13 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-5731 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL NDA authorized generic 20 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-5732 TABLET, FILM COATED, EXTENDED RELEASE 20 mg ORAL NDA authorized generic 20 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-5733 TABLET, FILM COATED, EXTENDED RELEASE 40 mg ORAL NDA authorized generic 20 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-5734 TABLET, FILM COATED, EXTENDED RELEASE 80 mg ORAL NDA authorized generic 20 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1556 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL NDA AUTHORIZED GENERIC 21 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1557 TABLET, FILM COATED, EXTENDED RELEASE 15 mg ORAL NDA AUTHORIZED GENERIC 21 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1558 TABLET, FILM COATED, EXTENDED RELEASE 20 mg ORAL NDA AUTHORIZED GENERIC 21 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1559 TABLET, FILM COATED, EXTENDED RELEASE 30 mg ORAL NDA AUTHORIZED GENERIC 21 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1560 TABLET, FILM COATED, EXTENDED RELEASE 40 mg ORAL NDA AUTHORIZED GENERIC 21 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1561 TABLET, FILM COATED, EXTENDED RELEASE 60 mg ORAL NDA AUTHORIZED GENERIC 21 sections
OXYCODONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1562 TABLET, FILM COATED, EXTENDED RELEASE 80 mg ORAL NDA AUTHORIZED GENERIC 21 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0121-4839 SOLUTION 5 mg ORAL ANDA 19 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0228-2876 TABLET 5 mg ORAL ANDA 19 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0228-2878 TABLET 15 mg ORAL ANDA 19 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0228-2879 TABLET 30 mg ORAL ANDA 19 sections
Oxycodone and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0228-2980 TABLET 2.50 mg ORAL ANDA 15 sections
Oxycodone and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0228-2981 TABLET 5 mg ORAL ANDA 15 sections
Oxycodone and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0228-2982 TABLET 7.50 mg ORAL ANDA 15 sections
Oxycodone and Acetaminophen HUMAN PRESCRIPTION DRUG LABEL 2 0228-2983 TABLET 10 mg ORAL ANDA 15 sections
Oxycodone hydrochloride and Ibuprofen HUMAN PRESCRIPTION DRUG LABEL 2 0228-4029 TABLET, FILM COATED 5 mg ORAL ANDA 16 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-6112 TABLET 5 mg ORAL ANDA 13 sections
Oxycodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-6113 TABLET 15 mg ORAL ANDA 13 sections