hydromorphone hydrochloride
These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS.HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, for oral use, CII Initial U.S. Approval: 1984
Approved
Approval ID
59b1e29f-3292-422c-bfdc-56803436c0ba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 24, 2020
Manufacturers
FDA
Ascent Pharmaceuticals, Inc.
DUNS: 080938961
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hydromorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-268
Application NumberANDA212133
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydromorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2020
FDA Product Classification
INGREDIENTS (14)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 16 mg in 1 1
Code: L960UP2KRW
Classification: ACTIB
POLYETHYLENE OXIDE 200000Inactive
Code: 11628IH70O
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ACETONEInactive
Code: 1364PS73AF
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
hydromorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-267
Application NumberANDA212133
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydromorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2020
FDA Product Classification
INGREDIENTS (14)
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
POLYETHYLENE OXIDE 200000Inactive
Code: 11628IH70O
Classification: IACT
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 12 mg in 1 1
Code: L960UP2KRW
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ACETONEInactive
Code: 1364PS73AF
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
hydromorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-266
Application NumberANDA212133
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydromorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2020
FDA Product Classification
INGREDIENTS (14)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: L960UP2KRW
Classification: ACTIB
POLYETHYLENE OXIDE 200000Inactive
Code: 11628IH70O
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ACETONEInactive
Code: 1364PS73AF
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
hydromorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43602-269
Application NumberANDA212133
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydromorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2020
FDA Product Classification
INGREDIENTS (16)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ACETONEInactive
Code: 1364PS73AF
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE OXIDE 200000Inactive
Code: 11628IH70O
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 32 mg in 1 1
Code: L960UP2KRW
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT