Metronidazole
These highlights do not include all the information needed to use Metronidazole Gel, 1% safely and effectively. See full prescribing information for Metronidazole Gel, 1%Metronidazole Gel for topical use. Initial U.S. Approval 1963
Approved
Approval ID
3c25a3f9-52fc-448e-a044-f63b9dadcd4a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2023
Manufacturers
FDA
Mayne Pharma Inc.
DUNS: 867220261
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 Code68308-663
Application NumberNDA021789
Product Classification
M
Marketing Category
C73605
G
Generic Name
metronidazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 24, 2023
FDA Product Classification
INGREDIENTS (9)
METRONIDAZOLEActive
Quantity: 10 mg in 1 g
Code: 140QMO216E
Classification: ACTIB
betadexInactive
Code: JV039JZZ3A
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
phenoxyethanolInactive
Code: HIE492ZZ3T
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
niacinamideInactive
Code: 25X51I8RD4
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT