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Diclofenac Sodium

Approved
Approval ID

bc185822-4754-ff6c-e053-2995a90a7c0e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 24, 2021

Manufacturers
FDA

Central Packaging

DUNS: 117617671

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Diclofenac Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code80175-1358
Application NumberANDA203818
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Sodium
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 24, 2021
FDA Product Classification

INGREDIENTS (1)

DICLOFENAC SODIUMActive
Quantity: 16.05 mg in 1 mL
Code: QTG126297Q
Classification: ACTIB

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Diclofenac Sodium - FDA Drug Approval Details