Emverm
These highlights do not include all the information needed to use EMVERM safely and effectively. See full prescribing information for EMVERM. EMVERM (mebendazole) chewable tablets, for oral use Initial U.S. Approval: 1974
Approved
Approval ID
a8c46363-f739-4f6e-bca8-1ce5e8d3f78d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2021
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
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 Code64896-669
Application NumberANDA073580
Product Classification
M
Marketing Category
C73584
G
Generic Name
mebendazole
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2023
FDA Product Classification
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MEBENDAZOLEActive
Quantity: 100 mg in 1 1
Code: 81G6I5V05I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT