Betamethasone Valerate
BETAMETHASONE VALERATE LOTION USP 0.1% (Potency expressed as betamethasone)
Approved
Approval ID
51faa793-547c-42c0-a01e-8b12e23e2d4b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2022
Manufacturers
FDA
STI Pharma LLC
DUNS: 832714070
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 Code54879-004
Application NumberANDA070052
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betamethasone Valerate
Product Specifications
Route of AdministrationCUTANEOUS
Effective DateNovember 17, 2022
FDA Product Classification
INGREDIENTS (5)
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT
BETAMETHASONE VALERATEActive
Quantity: 1 mg in 1 mL
Code: 9IFA5XM7R2
Classification: ACTIB