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
d265d143-343f-41ec-9cb4-18d83edb772b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-3794
Application NumberNDA018642
Product Classification
M
Marketing Category
C73594
G
Generic Name
Betamethasone Valerate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 5, 2022
FDA Product Classification
INGREDIENTS (12)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
POLYETHYLENE GLYCOL 1000Inactive
Code: U076Q6Q621
Classification: IACT
CETEARETH-15Inactive
Code: 867H4YOZ8Z
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
CHLOROCRESOLInactive
Code: 36W53O7109
Classification: IACT
BETAMETHASONE VALERATEActive
Quantity: 1.2 mg in 1 g
Code: 9IFA5XM7R2
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT