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
f5c7b8cb-a81f-4b13-b3c4-f6edaf880d3b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2019
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Albendazole
PRODUCT DETAILS
NDC Product Code0591-2712
Application NumberANDA208094
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 31, 2019
Generic NameAlbendazole
INGREDIENTS (12)
ALBENDAZOLEActive
Quantity: 200 mg in 1 1
Code: F4216019LN
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT