Betamethasone Valerate
BETAMETHASONE VALERATE CREAM USP, 0.1%BETAMETHASONE VALERATE OINTMENT USP, 0.1%(Potency expressed as betamethasone) Rx only FOR DERMATOLOGIC USE ONLY.NOT FOR OPHTHALMIC USE.
Approved
Approval ID
3cd0f7e2-e1bc-4ec7-91d3-58dfe37b04b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 30, 2022
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
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 Code53002-8450
Application NumberANDA070069
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betamethasone Valerate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 17, 2020
FDA Product Classification
INGREDIENTS (4)
BETAMETHASONE VALERATEActive
Quantity: 1.2 mg in 1 g
Code: 9IFA5XM7R2
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
LANOLIN ALCOHOLSInactive
Code: 884C3FA9HE
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT