Oxymorphone hydrochloride
These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. OXYMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CIIInitial U.S. Approval: 1959
Approved
Approval ID
3f4e703a-e398-42fd-8759-e398c79955f1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2022
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxymorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64896-701
Application NumberANDA079087
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2022
FDA Product Classification
INGREDIENTS (13)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Oxymorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64896-696
Application NumberANDA079087
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2022
FDA Product Classification
INGREDIENTS (14)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
Oxymorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64896-695
Application NumberANDA079087
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2022
FDA Product Classification
INGREDIENTS (14)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Oxymorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64896-700
Application NumberANDA079087
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2022
FDA Product Classification
INGREDIENTS (12)
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Oxymorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64896-697
Application NumberANDA079087
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2022
FDA Product Classification
INGREDIENTS (13)
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Oxymorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64896-699
Application NumberANDA079087
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2022
FDA Product Classification
INGREDIENTS (15)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Oxymorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64896-698
Application NumberANDA079087
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2022
FDA Product Classification
INGREDIENTS (10)
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT