Desvenlafaxine
These highlights do not include all the information needed to use DESVENLAFAXINE safely and effectively. See full prescribing information for DESVENLAFAXINE. DESVENLAFAXINE extended-release tablets, for oral use Initial U.S. Approval: 2008
Approved
Approval ID
9f74708c-6f6a-46cf-8c79-87a25c2bb6f8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 27, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Desvenlafaxine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-153
Application NumberNDA204150
Product Classification
M
Marketing Category
C73594
G
Generic Name
Desvenlafaxine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2023
FDA Product Classification
INGREDIENTS (12)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DESVENLAFAXINEActive
Quantity: 100 mg in 1 1
Code: NG99554ANW
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
Desvenlafaxine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-152
Application NumberNDA204150
Product Classification
M
Marketing Category
C73594
G
Generic Name
Desvenlafaxine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2023
FDA Product Classification
INGREDIENTS (11)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
DESVENLAFAXINEActive
Quantity: 50 mg in 1 1
Code: NG99554ANW
Classification: ACTIB
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT