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
72bcd320-39d6-49db-bc7b-d140d200076a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
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 Code54868-2994
Application NumberANDA018865
Product Classification
M
Marketing Category
C73584
G
Generic Name
betamethasone valerate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 16, 2010
FDA Product Classification
INGREDIENTS (3)
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
BETAMETHASONE VALERATEActive
Quantity: 1 mg in 1 g
Code: 9IFA5XM7R2
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
betamethasone valerate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0520
Application NumberANDA018861
Product Classification
M
Marketing Category
C73584
G
Generic Name
betamethasone valerate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 16, 2010
FDA Product Classification
INGREDIENTS (10)
BETAMETHASONE VALERATEActive
Quantity: 1 mg in 1 g
Code: 9IFA5XM7R2
Classification: ACTIB
CHLOROCRESOLInactive
Code: 36W53O7109
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
betamethasone valerate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5002
Application NumberANDA018866
Product Classification
M
Marketing Category
C73584
G
Generic Name
betamethasone valerate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 16, 2010
FDA Product Classification
INGREDIENTS (4)
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BETAMETHASONE VALERATEActive
Quantity: 1 mg in 1 mL
Code: 9IFA5XM7R2
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT