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BETAMETHASONE DIPROPIONATE

BETAMETHASONE DIPROPIONATE CREAM USP, 0.05%BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05%BETAMETHASONE DIPROPIONATE LOTION USP, 0.05%

Approved
Approval ID

13661456-0357-4e36-8266-1392c55f7c99

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 11, 2010

Manufacturers
FDA

STAT RX USA LLC

DUNS: 786036330

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

BETAMETHASONE DIPROPIONATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16590-032
Application NumberANDA019137
Product Classification
M
Marketing Category
C73584
G
Generic Name
BETAMETHASONE DIPROPIONATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 11, 2010
FDA Product Classification

INGREDIENTS (10)

BETAMETHASONE DIPROPIONATEActive
Quantity: .64 mg in 1 g
Code: 826Y60901U
Classification: ACTIB
CHLOROCRESOLInactive
Code: 36W53O7109
Classification: IACT
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

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BETAMETHASONE DIPROPIONATE - FDA Drug Approval Details