Pristiq
These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ. PRISTIQ (desvenlafaxine) Extended-Release Tablets, for oral useInitial U.S. Approval: 2008
Approved
Approval ID
0f43610c-f290-46ea-d186-4f998ed99fce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2023
Manufacturers
FDA
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
DUNS: 113008515
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
desvenlafaxine succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0008-1222
Application NumberNDA021992
Product Classification
M
Marketing Category
C73594
G
Generic Name
desvenlafaxine succinate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (10)
DESVENLAFAXINE SUCCINATEActive
Quantity: 100 mg in 1 1
Code: ZB22ENF0XR
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
desvenlafaxine succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0008-1211
Application NumberNDA021992
Product Classification
M
Marketing Category
C73594
G
Generic Name
desvenlafaxine succinate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (10)
DESVENLAFAXINE SUCCINATEActive
Quantity: 50 mg in 1 1
Code: ZB22ENF0XR
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
desvenlafaxine succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0008-1210
Application NumberNDA021992
Product Classification
M
Marketing Category
C73594
G
Generic Name
desvenlafaxine succinate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (10)
DESVENLAFAXINE SUCCINATEActive
Quantity: 25 mg in 1 1
Code: ZB22ENF0XR
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT