Venlafaxine
Venlafaxine Tablets, USP 8284401/0122 Rx only
Approved
Approval ID
d8899628-6e1b-40c6-9bc8-553d91ae2d0c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2022
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 3
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 Code68084-844
Application NumberANDA077653
Product Classification
M
Marketing Category
C73584
G
Generic Name
Venlafaxine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2022
FDA Product Classification
INGREDIENTS (7)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
Venlafaxine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68084-896
Application NumberANDA077653
Product Classification
M
Marketing Category
C73584
G
Generic Name
Venlafaxine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2022
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Venlafaxine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68084-856
Application NumberANDA077653
Product Classification
M
Marketing Category
C73584
G
Generic Name
Venlafaxine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2022
FDA Product Classification
INGREDIENTS (7)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM