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Albendazole

ALBENDAZOLE tablets, for oral use

Approved
Approval ID

77f18744-318f-4588-8c3a-68fc1eb95eb0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 13, 2022

Manufacturers
FDA

Zydus Lifesciences Limited

DUNS: 918596198

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 Code70771-1103
Application NumberANDA208979
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 13, 2022
Generic NameAlbendazole

INGREDIENTS (14)

ALBENDAZOLEActive
Quantity: 200 mg in 1 1
Code: F4216019LN
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
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Albendazole - FDA Approval | MedPath