oxymorphone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
opioid receptor antagonists/agonists, morphinan derivates	2034	76-41-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: oxymorphone 14-Hydroxydihydromorphinone (-)-Oxymorphone oxymorphone hydrochloride oxymorphone HCl	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) Molecular weight: 301.34 Formula: C17H19NO4 CLOGP: -0.48 LIPINSKI: 0 HAC: 5 HDO: 2 TPSA: 70 ALOGS: -1.07 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

oxymorphone
14-Hydroxydihydromorphinone
(-)-Oxymorphone
oxymorphone hydrochloride
oxymorphone HCl

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)

Molecular weight: 301.34
Formula: C17H19NO4
CLOGP: -0.48
LIPINSKI: 0
HAC: 5
HDO: 2
TPSA: 70
ALOGS: -1.07
ROTB: 0

Status: OFP

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

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
Drug abuse	223.51	25.72	91	2423	67519	56222034
Toxicity to various agents	216.02	25.72	130	2384	224434	56065119
Completed suicide	189.49	25.72	100	2414	133733	56155820
Drug use disorder	114.49	25.72	29	2485	4640	56284913
Intentional product misuse	94.48	25.72	46	2468	51458	56238095
Respiratory arrest	70.44	25.72	32	2482	30593	56258960
Injection site abscess	65.40	25.72	14	2500	1072	56288481
Cardio-respiratory arrest	63.14	25.72	36	2478	55285	56234268
Staphylococcal bacteraemia	56.24	25.72	17	2497	5192	56284361
Death	55.66	25.72	72	2442	341354	55948199
Intentional product use issue	54.73	25.72	41	2473	99692	56189861
Accidental poisoning	54.48	25.72	11	2503	632	56288921
Cardiac arrest	48.49	25.72	36	2478	86278	56203275
Injection site cellulitis	47.68	25.72	11	2503	1185	56288368
Endocarditis	47.20	25.72	15	2499	5401	56284152
Fanconi syndrome	41.70	25.72	10	2504	1273	56288280
Accidental death	38.16	25.72	10	2504	1822	56287731
Drug dependence	32.12	25.72	17	2497	22516	56267037
Overdose	28.45	25.72	29	2485	105801	56183752
Drug screen positive	27.74	25.72	9	2505	3455	56286098

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	306.33	35.66	135	1860	87623	31607726
Toxicity to various agents	181.51	35.66	122	1873	181365	31513984
Drug use disorder	123.68	35.66	32	1963	3951	31691398
Intentional product misuse	98.94	35.66	48	1947	37903	31657446
Drug dependence	98.66	35.66	41	1954	22538	31672811
Completed suicide	87.11	35.66	60	1935	91454	31603895
Accidental overdose	75.69	35.66	32	1963	18318	31677031
Injection site abscess	71.40	35.66	15	1980	741	31694608
Intentional product use issue	70.87	35.66	42	1953	49305	31646044
Drug withdrawal syndrome	68.46	35.66	30	1965	18720	31676629
Injection site cellulitis	58.65	35.66	12	1983	520	31694829
Endocarditis	47.93	35.66	17	1978	6068	31689281
Overdose	40.28	35.66	37	1958	84627	31610722
Therapeutic product effect decreased	37.87	35.66	24	1971	31598	31663751
Pneumomediastinum	37.51	35.66	11	1984	2146	31693203
Staphylococcal bacteraemia	37.31	35.66	15	1980	7533	31687816

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
Drug abuse	476.94	28.59	203	3455	147053	70777733
Toxicity to various agents	394.11	28.59	243	3415	381929	70542857
Completed suicide	270.42	28.59	159	3499	226976	70697810
Drug use disorder	238.57	28.59	60	3598	8091	70916695
Intentional product misuse	189.90	28.59	89	3569	79506	70845280
Injection site abscess	144.12	28.59	29	3629	1417	70923369
Intentional product use issue	126.46	28.59	78	3580	120064	70804722
Injection site cellulitis	106.91	28.59	23	3635	1559	70923227
Endocarditis	100.89	28.59	32	3626	9922	70914864
Respiratory arrest	100.45	28.59	51	3607	53882	70870904
Staphylococcal bacteraemia	97.51	28.59	32	3626	11050	70913736
Cardio-respiratory arrest	92.44	28.59	60	3598	100617	70824169
Accidental overdose	92.07	28.59	42	3616	35079	70889707
Death	91.20	28.59	121	3537	509940	70414846
Drug dependence	77.45	28.59	38	3620	37283	70887503
Cardiac arrest	63.75	28.59	58	3600	159776	70765010
Accidental death	63.10	28.59	18	3640	3890	70920896
Staphylococcal infection	54.34	28.59	34	3624	53370	70871416
Drug withdrawal syndrome	52.44	28.59	28	3630	32687	70892099
Accidental poisoning	42.85	28.59	11	3647	1599	70923187
Overdose	42.65	28.59	48	3610	169697	70755089
Acute kidney injury	40.85	28.59	81	3577	474543	70450243
Drug screen positive	40.07	28.59	14	3644	5826	70918960
Pneumomediastinum	34.82	28.59	11	3647	3359	70921427
Thrombotic microangiopathy	30.64	28.59	16	3642	17832	70906954
Substance abuse	29.70	28.59	13	3645	9824	70914962

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N02AA11	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
MeSH PA	D000759	Adjuvants, Anesthesia
MeSH PA	D000700	Analgesics
MeSH PA	D000701	Analgesics, Opioid
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 | 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 PHARMS	N021610	June 22, 2006	DISCN	TABLET, EXTENDED RELEASE	ORAL	7276250	Feb. 4, 2023	RELIEF OF MODERATE TO SEVERE PAIN
15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OPANA ER	ENDO PHARMS	N021610	Feb. 29, 2008	DISCN	TABLET, EXTENDED RELEASE	ORAL	7276250	Feb. 4, 2023	RELIEF OF MODERATE TO SEVERE PAIN
20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OPANA ER	ENDO PHARMS	N021610	June 22, 2006	DISCN	TABLET, EXTENDED RELEASE	ORAL	7276250	Feb. 4, 2023	RELIEF OF MODERATE TO SEVERE PAIN
30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OPANA ER	ENDO PHARMS	N021610	Feb. 29, 2008	DISCN	TABLET, EXTENDED RELEASE	ORAL	7276250	Feb. 4, 2023	RELIEF OF MODERATE TO SEVERE PAIN
40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OPANA ER	ENDO PHARMS	N021610	June 22, 2006	DISCN	TABLET, EXTENDED RELEASE	ORAL	7276250	Feb. 4, 2023	RELIEF OF MODERATE TO SEVERE PAIN
5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OPANA ER	ENDO PHARMS	N021610	June 22, 2006	DISCN	TABLET, EXTENDED RELEASE	ORAL	7276250	Feb. 4, 2023	RELIEF OF MODERATE TO SEVERE PAIN
7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OPANA ER	ENDO PHARMS	N021610	Feb. 29, 2008	DISCN	TABLET, EXTENDED RELEASE	ORAL	7276250	Feb. 4, 2023	RELIEF OF MODERATE TO SEVERE PAIN
10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OPANA ER	ENDO PHARMS	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 PHARMS	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 PHARMS	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 PHARMS	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 PHARMS	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 PHARMS	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 PHARMS	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)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
10MG	OPANA	ENDO PHARMS	N021611	June 22, 2006	DISCN	TABLET	ORAL	Oct. 25, 2022	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
5MG	OPANA	ENDO PHARMS	N021611	June 22, 2006	DISCN	TABLET	ORAL	Oct. 25, 2022	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Mu-type opioid receptor	GPCR	P35372	OPRM_HUMAN	AGONIST	Ki	9.44	WOMBAT-PK	CHEMBL
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN	AGONIST	Ki	6.83	WOMBAT-PK	CHEMBL
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN	AGONIST	Ki	7.30	CHEMBL	CHEMBL
Mu-type opioid receptor	GPCR		OPRM_RAT		Ki	9.01	CHEMBL
Mu-type opioid receptor	GPCR		OPRM_MOUSE		Ki	8.30	CHEMBL
Mu-type opioid receptor	GPCR		OPRM_CAVPO		Ki	9.27	CHEMBL
Delta-type opioid receptor	GPCR		OPRD_MOUSE		Ki	6.21	CHEMBL
Delta-type opioid receptor	GPCR		OPRD_RAT		Ki	7.09	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_CAVPO		Ki	7.24	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_RAT		Ki	7.02	CHEMBL
Opioid receptor	GPCR		OPRD_RAT OPRM_RAT OPRK_RAT SGMR1_RAT		IC50	10.89	CHEMBL
Opioid receptors; mu and delta	GPCR		OPRD_MOUSE OPRM_MOUSE		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

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	0054-0283	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	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	32 sections
Oxymorphone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1231	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	ANDA	32 sections
Oxymorphone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1232	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	ANDA	32 sections
Oxymorphone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1232	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	ANDA	32 sections
Oxymorphone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1233	TABLET, FILM COATED, EXTENDED RELEASE	20 mg	ORAL	ANDA	32 sections
Oxymorphone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1233	TABLET, FILM COATED, EXTENDED RELEASE	20 mg	ORAL	ANDA	32 sections
Oxymorphone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1234	TABLET, FILM COATED, EXTENDED RELEASE	40 mg	ORAL	ANDA	32 sections
Oxymorphone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1234	TABLET, FILM COATED, EXTENDED RELEASE	40 mg	ORAL	ANDA	32 sections
Oxymorphone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1315	TABLET, FILM COATED, EXTENDED RELEASE	7.50 mg	ORAL	ANDA	32 sections
Oxymorphone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1315	TABLET, FILM COATED, EXTENDED RELEASE	7.50 mg	ORAL	ANDA	32 sections
Oxymorphone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1316	TABLET, FILM COATED, EXTENDED RELEASE	15 mg	ORAL	ANDA	32 sections
Oxymorphone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1316	TABLET, FILM COATED, EXTENDED RELEASE	15 mg	ORAL	ANDA	32 sections
Oxymorphone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1317	TABLET, FILM COATED, EXTENDED RELEASE	30 mg	ORAL	ANDA	32 sections
Oxymorphone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1317	TABLET, FILM COATED, EXTENDED RELEASE	30 mg	ORAL	ANDA	32 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