oxymorphone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
opioid receptor antagonists/agonists, morphinan derivates 2034 76-41-5

Description:

MoleculeDescription

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:

PropertyValueReference
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):

PropertyDescriptionValueUnitConfidenceSimilarity
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:

DateAgencyCompanyOrphan
April 2, 1959 FDA ENDO PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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 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 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 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
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:

SourceCodeDescription
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
codeinedihydrocodeinehydromorphonemorphinenaloxonenaltrexonenicomorphineoxycodone

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (acidic/basic)
pKa1 9.31 acidic
pKa2 7.97 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA 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:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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