Betamethasone Dipropionate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

DUNS: 043838424

Effective Date

June 30, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Betamethasone(0.5 mg in 1 mL)

Products1

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

NDC Product Code

0168-0267

Application Number

ANDA077111

Marketing Category

ANDA (C73584)

Route of Administration

TOPICAL

Effective Date

June 4, 2019

Ingredients

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

isopropyl alcoholInactive

Code: ND2M416302Class: IACT

Code: 826Y60901UClass: ACTIMQuantity: 0.5 mg in 1 mL

waterInactive

Code: 059QF0KO0RClass: IACT

phosphoric acidInactive

Code: E4GA8884NNClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive

Code: 3980JIH2SWClass: IACT