Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
GlaxoSmithKline Inc.
Amneal Pharmaceuticals of New York LLC
205556368
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Albendazole
Product Details
NDC Product Code
0115-1701Application Number
NDA020666Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 30, 2019AlbendazoleActive
Code: F4216019LNClass: ACTIBQuantity: 200 mg in 1 1
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SACCHARIN SODIUM MONOHYDRATEInactive
Code: A9CO00M9HVClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT