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Albendazole

ALBENDAZOLE TABLETS. 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

8de337eb-92e1-15b5-e053-2a95a90ac4f1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 2, 2023

Manufacturers
FDA

Golden State Medical Supply

DUNS: 603184490

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 Code51407-258
Application NumberANDA211117
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albendazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 2, 2023
FDA Product Classification

INGREDIENTS (9)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ALBENDAZOLEActive
Quantity: 200 mg in 1 1
Code: F4216019LN
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

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Albendazole - FDA Drug Approval Details