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
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prednisone
Product Details
NDC Product Code
53002-3090Application Number
ANDA040362Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 7, 2017PrednisoneActive
Code: VB0R961HZTClass: ACTIBQuantity: 10 mg in 1 1
Starch, CornInactive
Code: O8232NY3SJClass: IACT
Magnesium stearateInactive
Code: 70097M6I30Class: IACT
Sodium lauryl sulfateInactive
Code: 368GB5141JClass: IACT
Starch, PotatoInactive
Code: 8I089SAH3TClass: IACT
Lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
Prednisone
Product Details
NDC Product Code
53002-3250Application Number
ANDA040362Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 7, 2017PrednisoneActive
Code: VB0R961HZTClass: ACTIBQuantity: 20 mg in 1 1
Lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
Magnesium stearateInactive
Code: 70097M6I30Class: IACT
Sodium lauryl sulfateInactive
Code: 368GB5141JClass: IACT
Starch, PotatoInactive
Code: 8I089SAH3TClass: IACT
Aluminum OxideInactive
Code: LMI26O6933Class: IACT
Fd&c Yellow No. 6Inactive
Code: H77VEI93A8Class: IACT
Starch, CornInactive
Code: O8232NY3SJClass: IACT