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, CII Initial U.S. Approval: 1959
Approved
Approval ID
e6b1c980-bb0c-4805-8e0d-9f8f8e9bfdde
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2016
Manufacturers
FDA
Ranbaxy Pharmaceuticals Inc.
DUNS: 937890044
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 Code63304-223
Application NumberANDA203506
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2016
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
Oxymorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-221
Application NumberANDA203506
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2016
FDA Product Classification
INGREDIENTS (9)
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
Oxymorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-219
Application NumberANDA203506
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2016
FDA Product Classification
INGREDIENTS (11)
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
Oxymorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-220
Application NumberANDA203506
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2016
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
Oxymorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-224
Application NumberANDA203506
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2016
FDA Product Classification
INGREDIENTS (11)
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Oxymorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-222
Application NumberANDA203506
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2016
FDA Product Classification
INGREDIENTS (12)
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
Oxymorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-218
Application NumberANDA203506
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxymorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2016
FDA Product Classification
INGREDIENTS (10)
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT