venlafaxine
These highlights do not include all the information needed to use VENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for VENLAFAXINE EXTENDED-RELEASE TABLETS. VENLAFAXINE extended-release tablets, for oral useInitial U.S. Approval: 1993
Approved
Approval ID
e81a2daf-b8b2-7c05-b532-bc775700b100
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2023
Manufacturers
FDA
Almatica Pharma LLC
DUNS: 962454505
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
venlafaxine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52427-632
Application NumberNDA215429
Product Classification
M
Marketing Category
C73594
G
Generic Name
venlafaxine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2019
FDA Product Classification
INGREDIENTS (19)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIO METHACRYLATE COPOLYMER TYPE AInactive
Code: 8GQS4E66YY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
VENLAFAXINE BESYLATE MONOHYDRATEActive
Quantity: 112.5 mg in 1 1
Code: 18XP3YT5NH
Classification: ACTIM