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 useInitial U.S. Approval: 1996
Approved
Approval ID
5cf8a5ba-578c-439e-b203-49fb8b1cd108
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code72162-1309
Application NumberANDA210011
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 25, 2023
Generic NameAlbendazole
INGREDIENTS (9)
ALBENDAZOLEActive
Quantity: 200 mg in 1 1
Code: F4216019LN
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT