venlafaxine hydrochloride
These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE capsules, for oral useInitial U.S. Approval: 1997
Approved
Approval ID
5351fe67-17d9-42ec-9e8b-6585fdb9e29e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 21, 2022
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
venlafaxine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-035
Application NumberANDA090174
Product Classification
M
Marketing Category
C73584
G
Generic Name
venlafaxine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2022
FDA Product Classification
INGREDIENTS (12)
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive
Code: P2OM2Q86BI
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
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
venlafaxine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-036
Application NumberANDA090174
Product Classification
M
Marketing Category
C73584
G
Generic Name
venlafaxine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2022
FDA Product Classification
INGREDIENTS (12)
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive
Code: P2OM2Q86BI
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
venlafaxine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-034
Application NumberANDA090174
Product Classification
M
Marketing Category
C73584
G
Generic Name
venlafaxine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2022
FDA Product Classification
INGREDIENTS (11)
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive
Code: P2OM2Q86BI
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT