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Betamethasone Valerate

BETAMETHASONE VALERATE CREAM USP, 0.1% BETAMETHASONE VALERATE OINTMENT USP, 0.1% BETAMETHASONE VALERATE LOTION USP, 0.1% (Potency expressed as betamethasone)

Approved
Approval ID

eeb337ba-0d7e-42cd-840a-78783b5688d7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 22, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

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 Code21695-586
Application NumberANDA018865
Product Classification
M
Marketing Category
C73584
G
Generic Name
betamethasone valerate
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 23, 2009
FDA Product Classification

INGREDIENTS (3)

petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
betamethasone valerateActive
Quantity: 1 mg in 1 g
Code: 9IFA5XM7R2
Classification: ACTIB
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT

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Betamethasone Valerate - FDA Drug Approval Details