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
NDC Product Code43602-268
Application NumberANDA212133
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 24, 2020
Generic Namehydromorphone hydrochloride
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
NDC Product Code43602-267
Application NumberANDA212133
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 24, 2020
Generic Namehydromorphone hydrochloride
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
NDC Product Code43602-266
Application NumberANDA212133
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 24, 2020
Generic Namehydromorphone hydrochloride
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
NDC Product Code43602-269
Application NumberANDA212133
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 24, 2020
Generic Namehydromorphone hydrochloride
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