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Betamethasone Valerate

BETAMETHASONE VALERATE CREAM, USP 0.1% BETAMETHASONE VALERATE OINTMENT, USP 0.1%

Approved
Approval ID

7fc14c26-2cad-43c5-82c7-ced4cc845292

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 1, 2019

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.

Betamethasone Valerate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63187-276
Application NumberANDA070051
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betamethasone Valerate
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 1, 2019
FDA Product Classification

INGREDIENTS (3)

BETAMETHASONE VALERATEActive
Quantity: 1.2 mg in 1 g
Code: 9IFA5XM7R2
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT

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Betamethasone Valerate - FDA Drug Approval Details