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venlafaxine

Venlafaxine Tablets, USP Rx only

Approved
Approval ID

87e94c9a-d3b7-125f-e053-2a95a90a07b1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 17, 2021

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

Products 1

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 Code68071-4876
Application NumberANDA090555
Product Classification
M
Marketing Category
C73584
G
Generic Name
venlafaxine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2021
FDA Product Classification

INGREDIENTS (8)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM

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venlafaxine - FDA Drug Approval Details