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oxymorphone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| opioid receptor antagonists/agonists, morphinan derivates | 2034 | 76-41-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
An opioid analgesic with actions and uses similar to those of MORPHINE, apart from an absence of cough suppressant activity. It is used in the treatment of moderate to severe pain, including pain in obstetrics. It may also be used as an adjunct to anesthesia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1092)
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 24 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 1.90 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.43 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 10 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 0.388 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 3.945 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 3.443 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 19.187 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 79.400 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 85.960 | % | High | 1 |
| herg | hERG pIC50 | 4.478 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 4.140 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.639 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 84 | % | High | 1 |
| kinase-safety-class | ACVR2A,ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK2,CDK4,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK2,JAK3,KDR,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIM2,PLK1,PRKDC,SIK2,STK33,SYK,TEK,TGFBR1,ZAP70 | 45 | |||
| kinase-selectivity-class | EIF2AK3,GRK2,MAP2K6,MAP3K14,TEK | 5 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 1.570 | Moderate | 0.76 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 4.325 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 103.276 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 78.790 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 12.303 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 0 | Moderate | 0.76 | |
| pppb | Pig plasma protein binding (% unbound) | 89.740 | % | High | 1 |
| rat-kpuu-brain | Rat brain Kpuu | 0.072 | % | Moderate | 0.76 |
| rh-clint | Rat hepatocyte intrinsic clearance | 70.146 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 90.480 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 73.270 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 961.612 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 2, 1959 | FDA | ENDO PHARMS |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Toxicity to various agents | 301.51 | 27.94 | 158 | 2793 | 287688 | 90337808 |
| Drug abuse | 266.19 | 27.94 | 100 | 2851 | 82247 | 90543249 |
| Completed suicide | 249.29 | 27.94 | 112 | 2839 | 144946 | 90480550 |
| Intentional product misuse | 109.89 | 27.94 | 55 | 2896 | 89549 | 90535947 |
| Drug use disorder | 106.86 | 27.94 | 29 | 2922 | 8314 | 90617182 |
| Respiratory arrest | 77.55 | 27.94 | 32 | 2919 | 33279 | 90592217 |
| Cardio-respiratory arrest | 69.31 | 27.94 | 36 | 2915 | 63104 | 90562392 |
| Injection site abscess | 65.73 | 27.94 | 14 | 2937 | 1440 | 90624056 |
| Death | 63.51 | 27.94 | 76 | 2875 | 456475 | 90169021 |
| Staphylococcal bacteraemia | 55.49 | 27.94 | 17 | 2934 | 7452 | 90618044 |
| Accidental poisoning | 53.55 | 27.94 | 11 | 2940 | 949 | 90624547 |
| Cardiac arrest | 52.37 | 27.94 | 36 | 2915 | 104899 | 90520597 |
| Injection site cellulitis | 48.51 | 27.94 | 11 | 2940 | 1510 | 90623986 |
| Endocarditis | 47.83 | 27.94 | 15 | 2936 | 7098 | 90618398 |
| Overdose | 41.38 | 27.94 | 37 | 2914 | 157672 | 90467824 |
| Fanconi syndrome | 40.71 | 27.94 | 10 | 2941 | 1933 | 90623563 |
| Accidental death | 40.19 | 27.94 | 10 | 2941 | 2038 | 90623458 |
| Intentional product use issue | 40.15 | 27.94 | 42 | 2909 | 216850 | 90408646 |
| Drug screen positive | 38.63 | 27.94 | 11 | 2940 | 3746 | 90621750 |
| Drug dependence | 32.95 | 27.94 | 17 | 2934 | 29310 | 90596186 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug abuse | 352.19 | 40.19 | 148 | 2048 | 104623 | 42514516 |
| Toxicity to various agents | 282.06 | 40.19 | 163 | 2033 | 228973 | 42390166 |
| Completed suicide | 105.32 | 40.19 | 64 | 2132 | 96401 | 42522738 |
| Drug use disorder | 99.84 | 40.19 | 32 | 2164 | 10301 | 42608838 |
| Drug dependence | 89.91 | 40.19 | 39 | 2157 | 29055 | 42590084 |
| Intentional product misuse | 85.80 | 40.19 | 48 | 2148 | 61852 | 42557287 |
| Drug withdrawal syndrome | 73.53 | 40.19 | 31 | 2165 | 21518 | 42597621 |
| Injection site abscess | 69.74 | 40.19 | 15 | 2181 | 1017 | 42618122 |
| Accidental overdose | 65.39 | 40.19 | 31 | 2165 | 28299 | 42590840 |
| Intentional product use issue | 64.06 | 40.19 | 42 | 2154 | 71791 | 42547348 |
| Injection site cellulitis | 58.35 | 40.19 | 12 | 2184 | 654 | 42618485 |
| Overdose | 51.78 | 40.19 | 43 | 2153 | 105221 | 42513918 |
| Endocarditis | 46.39 | 40.19 | 17 | 2179 | 8135 | 42611004 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Toxicity to various agents | 592.86 | 28.60 | 312 | 4023 | 480243 | 110104721 |
| Drug abuse | 580.41 | 28.60 | 228 | 4107 | 177183 | 110407781 |
| Completed suicide | 353.47 | 28.60 | 177 | 4158 | 242204 | 110342760 |
| Drug use disorder | 207.45 | 28.60 | 60 | 4275 | 18014 | 110566950 |
| Intentional product misuse | 195.79 | 28.60 | 98 | 4237 | 132806 | 110452158 |
| Injection site abscess | 142.57 | 28.60 | 29 | 4306 | 1977 | 110582987 |
| Respiratory arrest | 116.21 | 28.60 | 53 | 4282 | 58246 | 110526718 |
| Injection site cellulitis | 107.58 | 28.60 | 23 | 4312 | 1997 | 110582967 |
| Cardio-respiratory arrest | 105.00 | 28.60 | 62 | 4273 | 115774 | 110469190 |
| Death | 101.06 | 28.60 | 130 | 4205 | 698739 | 109886225 |
| Endocarditis | 100.22 | 28.60 | 32 | 4303 | 13339 | 110571625 |
| Intentional product use issue | 96.82 | 28.60 | 79 | 4256 | 247827 | 110337137 |
| Staphylococcal bacteraemia | 93.25 | 28.60 | 32 | 4303 | 16656 | 110568308 |
| Accidental overdose | 84.40 | 28.60 | 41 | 4294 | 51793 | 110533171 |
| Drug dependence | 73.79 | 28.60 | 37 | 4298 | 49983 | 110534981 |
| Cardiac arrest | 71.12 | 28.60 | 60 | 4275 | 196693 | 110388271 |
| Overdose | 67.95 | 28.60 | 63 | 4272 | 233731 | 110351233 |
| Accidental death | 63.56 | 28.60 | 18 | 4317 | 4991 | 110579973 |
| Drug screen positive | 59.18 | 28.60 | 18 | 4317 | 6392 | 110578572 |
| Drug withdrawal syndrome | 55.68 | 28.60 | 28 | 4307 | 38026 | 110546938 |
| Staphylococcal infection | 54.46 | 28.60 | 34 | 4301 | 69910 | 110515054 |
| Acute kidney injury | 44.66 | 28.60 | 85 | 4250 | 635345 | 109949619 |
| Accidental poisoning | 41.10 | 28.60 | 11 | 4324 | 2476 | 110582488 |
| Thrombotic microangiopathy | 38.43 | 28.60 | 20 | 4315 | 29129 | 110555835 |
| Pneumomediastinum | 33.44 | 28.60 | 11 | 4324 | 5025 | 110579939 |
| Substance abuse | 30.16 | 28.60 | 13 | 4322 | 12450 | 110572514 |
| Oesophageal rupture | 29.94 | 28.60 | 7 | 4328 | 910 | 110584054 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N02AA11 | NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids |
| MeSH PA | D000700 | Analgesics |
| MeSH PA | D000701 | Analgesics, Opioid |
| MeSH PA | D000759 | Adjuvants, Anesthesia |
| MeSH PA | D002492 | Central Nervous System Depressants |
| MeSH PA | D009294 | Narcotics |
| MeSH PA | D018689 | Sensory System Agents |
| FDA MoA | N0000175684 | Full Opioid Agonists |
| FDA EPC | N0000175690 | Opioid Agonist |
Related Drugs by ATC class:
N02AA Natural opium alkaloids 8 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Pain | indication | 22253000 | |
| General anesthesia | indication | 50697003 | |
| Severe pain | indication | 76948002 | |
| Chronic pain | indication | 82423001 | |
| Labor pain | indication | 247412007 | |
| Local anesthesia | indication | 386761002 | |
| Severe Pain with Opioid Tolerance | indication | ||
| Chronic Pain with Opioid Tolerance | indication | ||
| Anxiety due to Cardiac Asthma | indication | ||
| Suicidal thoughts | contraindication | 6471006 | |
| Dependent drug abuse | contraindication | 6525002 | |
| Alcohol withdrawal delirium | contraindication | 8635005 | |
| Asthenia | contraindication | 13791008 | |
| Constipation | contraindication | 14760008 | DOID:2089 |
| Mood swings | contraindication | 18963009 | |
| Inflammatory bowel disease | contraindication | 24526004 | DOID:0050589 |
| Alcohol intoxication | contraindication | 25702006 | |
| Shock | contraindication | 27942005 | |
| Hypercapnia | contraindication | 29596007 | |
| Dehydration | contraindication | 34095006 | |
| Disorder of gallbladder | contraindication | 39621005 | DOID:0060262 |
| Hypothyroidism | contraindication | 40930008 | DOID:1459 |
| Conduction disorder of the heart | contraindication | 44808001 | |
| Low blood pressure | contraindication | 45007003 | |
| Bradycardia | contraindication | 48867003 | |
| Ulcerative colitis | contraindication | 64766004 | DOID:8577 |
| Substance abuse | contraindication | 66214007 | |
| Benign intracranial hypertension | contraindication | 68267002 | DOID:11459 |
| Urethral stricture | contraindication | 76618002 | |
| Decreased respiratory function | contraindication | 80954004 | |
| Injury of head | contraindication | 82271004 | |
| Cor pulmonale | contraindication | 83291003 | DOID:8515 |
| Pulmonary emphysema | contraindication | 87433001 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Acute abdominal pain | contraindication | 116290004 | |
| Neoplasm of brain | contraindication | 126952004 | DOID:1319 |
| Seizure disorder | contraindication | 128613002 | |
| Drug-induced psychosis | contraindication | 191483003 | DOID:1742 |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Morbid obesity | contraindication | 238136002 | DOID:11981 |
| Benign prostatic hyperplasia | contraindication | 266569009 | |
| Retention of urine | contraindication | 267064002 | |
| Exacerbation of asthma | contraindication | 281239006 | |
| Lesion of brain | contraindication | 301766008 | |
| Coma | contraindication | 371632003 | |
| Primary adrenocortical insufficiency | contraindication | 373662000 | |
| Operation on gastrointestinal tract | contraindication | 386621005 | |
| Hypoxia | contraindication | 389086002 | |
| Central nervous system depression | contraindication | 418072004 | |
| Dysfunction of sphincter of Oddi | contraindication | 430887001 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.31 | acidic |
| pKa2 | 7.97 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OPANA ER | ENDO OPERATIONS | N021610 | June 22, 2006 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8808737 | June 21, 2027 | DOSE MODIFICATION FOR RENAL IMPAIRMENT |
| 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OPANA ER | ENDO OPERATIONS | N021610 | Feb. 29, 2008 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8808737 | June 21, 2027 | DOSE MODIFICATION FOR RENAL IMPAIRMENT |
| 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OPANA ER | ENDO OPERATIONS | N021610 | June 22, 2006 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8808737 | June 21, 2027 | DOSE MODIFICATION FOR RENAL IMPAIRMENT |
| 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OPANA ER | ENDO OPERATIONS | N021610 | Feb. 29, 2008 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8808737 | June 21, 2027 | DOSE MODIFICATION FOR RENAL IMPAIRMENT |
| 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OPANA ER | ENDO OPERATIONS | N021610 | June 22, 2006 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8808737 | June 21, 2027 | DOSE MODIFICATION FOR RENAL IMPAIRMENT |
| 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OPANA ER | ENDO OPERATIONS | N021610 | June 22, 2006 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8808737 | June 21, 2027 | DOSE MODIFICATION FOR RENAL IMPAIRMENT |
| 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OPANA ER | ENDO OPERATIONS | N021610 | Feb. 29, 2008 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8808737 | June 21, 2027 | DOSE MODIFICATION FOR RENAL IMPAIRMENT |
| 10MG | OPANA ER | ENDO PHARMS | N201655 | Dec. 9, 2011 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8808737 | June 21, 2027 | METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE |
| 15MG | OPANA ER | ENDO PHARMS | N201655 | Dec. 9, 2011 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8808737 | June 21, 2027 | METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE |
| 20MG | OPANA ER | ENDO PHARMS | N201655 | Dec. 9, 2011 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8808737 | June 21, 2027 | METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE |
| 30MG | OPANA ER | ENDO PHARMS | N201655 | Dec. 9, 2011 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8808737 | June 21, 2027 | METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE |
| 40MG | OPANA ER | ENDO PHARMS | N201655 | Dec. 9, 2011 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8808737 | June 21, 2027 | METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE |
| 5MG | OPANA ER | ENDO PHARMS | N201655 | Dec. 9, 2011 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8808737 | June 21, 2027 | METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE |
| 7.5MG | OPANA ER | ENDO PHARMS | N201655 | Dec. 9, 2011 | DISCN | TABLET, EXTENDED RELEASE | ORAL | 8808737 | June 21, 2027 | METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Kappa-type opioid receptor | GPCR | AGONIST | Ki | 6.83 | WOMBAT-PK | CHEMBL | |||
| Mu-type opioid receptor | GPCR | AGONIST | Ki | 9.44 | WOMBAT-PK | CHEMBL | |||
| Delta-type opioid receptor | GPCR | AGONIST | Ki | 7.30 | CHEMBL | CHEMBL | |||
| Mu-type opioid receptor | GPCR | Ki | 9.01 | CHEMBL | |||||
| Mu-type opioid receptor | GPCR | Ki | 8.30 | CHEMBL | |||||
| Mu-type opioid receptor | GPCR | Ki | 9.27 | CHEMBL | |||||
| Delta-type opioid receptor | GPCR | Ki | 6.21 | CHEMBL | |||||
| Delta-type opioid receptor | GPCR | Ki | 7.09 | CHEMBL | |||||
| Kappa-type opioid receptor | GPCR | Ki | 7.24 | CHEMBL | |||||
| Kappa-type opioid receptor | GPCR | Ki | 7.02 | CHEMBL | |||||
| Opioid receptor | GPCR | IC50 | 10.89 | CHEMBL | |||||
| Opioid receptors; mu and delta | GPCR | Ki | 8.33 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4019871 | VUID |
| N0000147956 | NUI |
| D00844 | KEGG_DRUG |
| 357-07-3 | SECONDARY_CAS_RN |
| 4019062 | VANDF |
| 4019871 | VANDF |
| C0030073 | UMLSCUI |
| CHEBI:7865 | CHEBI |
| CHEMBL963 | ChEMBL_ID |
| DB01192 | DRUGBANK_ID |
| CHEMBL1200794 | ChEMBL_ID |
| D010111 | MESH_DESCRIPTOR_UI |
| 5284604 | PUBCHEM_CID |
| 7094 | IUPHAR_LIGAND_ID |
| 937 | INN_ID |
| 9VXA968E0C | UNII |
| 7814 | RXNORM |
| 177273 | MMSL |
| 5220 | MMSL |
| d00833 | MMSL |
| 001548 | NDDF |
| 004623 | NDDF |
| 24751001 | SNOMEDCT_US |
| 370266008 | SNOMEDCT_US |
| 69899006 | SNOMEDCT_US |
| 9VXA968E0C | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Oxymorphone Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0283 | TABLET | 5 mg | ORAL | ANDA | 33 sections |
| Oxymorphone Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0284 | TABLET | 10 mg | ORAL | ANDA | 33 sections |
| Oxymorphone hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1231 | TABLET, FILM COATED, EXTENDED RELEASE | 5 mg | ORAL | ANDA | 33 sections |
| Oxymorphone hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1232 | TABLET, FILM COATED, EXTENDED RELEASE | 10 mg | ORAL | ANDA | 33 sections |
| Oxymorphone hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1233 | TABLET, FILM COATED, EXTENDED RELEASE | 20 mg | ORAL | ANDA | 33 sections |
| Oxymorphone hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1234 | TABLET, FILM COATED, EXTENDED RELEASE | 40 mg | ORAL | ANDA | 33 sections |
| Oxymorphone hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1315 | TABLET, FILM COATED, EXTENDED RELEASE | 7.50 mg | ORAL | ANDA | 33 sections |
| Oxymorphone hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1316 | TABLET, FILM COATED, EXTENDED RELEASE | 15 mg | ORAL | ANDA | 33 sections |
| Oxymorphone hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1317 | TABLET, FILM COATED, EXTENDED RELEASE | 30 mg | ORAL | ANDA | 33 sections |
| Oxymorphone Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10702-070 | TABLET | 5 mg | ORAL | ANDA | 35 sections |
| Oxymorphone Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10702-071 | TABLET | 10 mg | ORAL | ANDA | 35 sections |
| Oxymorphone Hydrochloride | Human Prescription Drug Label | 1 | 13107-103 | TABLET | 5 mg | ORAL | ANDA | 33 sections |
| Oxymorphone Hydrochloride | Human Prescription Drug Label | 1 | 13107-104 | TABLET | 10 mg | ORAL | ANDA | 33 sections |
| OPANAER | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-609 | TABLET, FILM COATED, EXTENDED RELEASE | 40 mg | ORAL | NDA | 18 sections |
| OPANAER | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-747 | TABLET, FILM COATED, EXTENDED RELEASE | 10 mg | ORAL | NDA | 18 sections |
| OPANA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-765 | TABLET | 10 mg | ORAL | NDA | 30 sections |
| OPANAER | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-767 | TABLET, FILM COATED, EXTENDED RELEASE | 5 mg | ORAL | NDA | 18 sections |
| OPANA ER | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-948 | TABLET, FILM COATED, EXTENDED RELEASE | 5 mg | ORAL | NDA | 27 sections |
| OPANA ER | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-949 | TABLET, FILM COATED, EXTENDED RELEASE | 10 mg | ORAL | NDA | 27 sections |
| OXYMORPHONE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-929 | TABLET | 5 mg | ORAL | ANDA | 21 sections |
| OXYMORPHONE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-930 | TABLET | 10 mg | ORAL | ANDA | 21 sections |
| Oxymorphone Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42806-330 | TABLET | 5 mg | ORAL | ANDA | 31 sections |
| Oxymorphone Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42806-331 | TABLET | 10 mg | ORAL | ANDA | 31 sections |
| Oxymorphone Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-6379 | TABLET | 10 mg | ORAL | ANDA | 32 sections |
| Oxymorphone hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63304-218 | TABLET, FILM COATED, EXTENDED RELEASE | 5 mg | ORAL | ANDA | 33 sections |
| Oxymorphone hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63304-219 | TABLET, FILM COATED, EXTENDED RELEASE | 7.50 mg | ORAL | ANDA | 33 sections |
| Oxymorphone hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63304-220 | TABLET, FILM COATED, EXTENDED RELEASE | 10 mg | ORAL | ANDA | 33 sections |
| Oxymorphone hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63304-221 | TABLET, FILM COATED, EXTENDED RELEASE | 15 mg | ORAL | ANDA | 33 sections |
| Oxymorphone hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63304-222 | TABLET, FILM COATED, EXTENDED RELEASE | 20 mg | ORAL | ANDA | 33 sections |
| Oxymorphone hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63304-223 | TABLET, FILM COATED, EXTENDED RELEASE | 30 mg | ORAL | ANDA | 33 sections |