MEBENDAZOLE
MEBENDAZOLE TABLETS, USP 100 mg9107
Approved
Approval ID
fa778759-2b9a-4446-ba06-d3c486019e79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 29, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
mebendazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3732
Application NumberANDA073580
Product Classification
M
Marketing Category
C73584
G
Generic Name
mebendazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2011
FDA Product Classification
INGREDIENTS (10)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MEBENDAZOLEActive
Quantity: 100 mg in 1 1
Code: 81G6I5V05I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT