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Venlafaxine

Venlafaxine Tablets, USP

Approved
Approval ID

b5fc0187-590c-4bb9-a910-821eb0dc1fc8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 1, 2021

Manufacturers
FDA

Proficient Rx LP

DUNS: 079196022

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 Code63187-414
Application NumberANDA077653
Product Classification
M
Marketing Category
C73584
G
Generic Name
Venlafaxine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2021
FDA Product Classification

INGREDIENTS (7)

VENLAFAXINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

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Venlafaxine - FDA Drug Approval Details