Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
RPK Pharmaceuticals, Inc.
RPK Pharmaceuticals, Inc.
147096275
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Betamethasone Valerate
Product Details
NDC Product Code
53002-8450Application Number
ANDA070069Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
December 17, 2020BetamethasoneActive
Code: 9IFA5XM7R2Class: ACTIBQuantity: 1.2 mg in 1 g
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
LANOLIN ALCOHOLSInactive
Code: 884C3FA9HEClass: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT