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Betamethasone Valerate

Betamethasone Valerate Cream USP, 0.1%

Approved
Approval ID

f242cdf5-6921-431f-8add-4d17887ebc93

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 14, 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 Code21695-584
Application NumberANDA070062
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betamethasone Valerate
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 4, 2008
FDA Product Classification

INGREDIENTS (12)

Betamethasone ValerateActive
Quantity: 1 mg in 1 g
Code: 9IFA5XM7R2
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
CHLOROCRESOLInactive
Code: 36W53O7109
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
phosphoric acidInactive
Code: E4GA8884NN
Classification: IACT

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Betamethasone Valerate - FDA Drug Approval Details