VERMOX
These highlights do not include all the information needed to use VERMOX™ CHEWABLE safely and effectively. See full prescribing information for VERMOX™ CHEWABLE. VERMOX™ CHEWABLE (mebendazole chewable tablets), for oral use Initial U.S. Approval: 1974
Approved
Approval ID
a720c424-517a-461b-8e13-6c37caf8aa3f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2021
Manufacturers
FDA
Janssen Pharmaceuticals, Inc.
DUNS: 063137772
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 Code50458-675
Application NumberNDA208398
Product Classification
M
Marketing Category
C73594
G
Generic Name
mebendazole
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2021
FDA Product Classification
INGREDIENTS (8)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
mebendazoleActive
Quantity: 500 mg in 1 1
Code: 81G6I5V05I
Classification: ACTIB
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
strawberryInactive
Code: 4J2TY8Y81V
Classification: IACT
sucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT