Albendazole
These highlights do not include all the information needed to use ALBENDAZOLE TABLETS safely and effectively. See full prescribing information for ALBENDAZOLE TABLETS. ALBENDAZOLE tablets, for oral use Initial U.S. Approval: 1996
Approved
Approval ID
06b5eefc-0b95-4862-b9b6-770063f2adf0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2019
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
albendazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1701
Application NumberNDA020666
Product Classification
M
Marketing Category
C73594
G
Generic Name
albendazole
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2019
FDA Product Classification
INGREDIENTS (11)
ALBENDAZOLEActive
Quantity: 200 mg in 1 1
Code: F4216019LN
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SACCHARIN SODIUM MONOHYDRATEInactive
Code: A9CO00M9HV
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT