metronidazole
Metronidazole Tablets, USP Rx only
Approved
Approval ID
99886f54-4ebe-4a2d-b779-bcfbb0634db1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2025
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code72162-2468
Application NumberANDA070772
Product Classification
M
Marketing Category
C73584
G
Generic Name
metronidazole
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2025
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
METRONIDAZOLEActive
Quantity: 125 mg in 1 1
Code: 140QMO216E
Classification: ACTIB