Metronidazole
Metronidazole Tablets, USP
Approved
Approval ID
f426cddc-8b70-c0a7-e053-2995a90a74e0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 9, 2025
Manufacturers
FDA
Redpharm Drug, inc.
DUNS: 828374897
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metronidazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-0078
Application NumberANDA070033
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metronidazole
Product Specifications
Route of AdministrationORAL
Effective DateApril 9, 2025
FDA Product Classification
INGREDIENTS (5)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
METRONIDAZOLEActive
Quantity: 500 mg in 1 1
Code: 140QMO216E
Classification: ACTIB