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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

894dc8f3-9eae-400e-b30d-2d347d3500dc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 26, 2012

Manufacturers
FDA

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

DUNS: 831276758

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 Code49999-222
Application NumberANDA019137
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betamethasone Dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 26, 2012
FDA Product Classification

INGREDIENTS (9)

waterInactive
Code: 059QF0KO0R
Classification: IACT
betamethasone dipropionateActive
Quantity: 0.5 mg in 1 g
Code: 826Y60901U
Classification: ACTIM
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
sodium phosphate, monobasicInactive
Code: 3980JIH2SW
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1S
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
phosphoric acidInactive
Code: E4GA8884NN
Classification: IACT
chlorocresolInactive
Code: 36W53O7109
Classification: IACT

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Betamethasone Dipropionate - FDA Drug Approval Details