Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Fukuzyu Pharmaceutical Co., Ltd.
Vyera Pharmaceuticals LLC
692442510
Patheon Manufacturing Services LLC
Vyera Pharmaceuticals LLC
079415560
Novitium Pharma LLC
Vyera Pharmaceuticals LLC
080301870
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Daraprim
Product Details
NDC Product Code
69413-330Application Number
NDA008578Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
November 24, 2021STARCH, POTATOInactive
Code: 8I089SAH3TClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
PyrimethamineActive
Code: Z3614QOX8WClass: ACTIBQuantity: 25 mg in 1 1
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT