Metronidazole
Metronidazole Gel USP, 0.75%
Approved
Approval ID
8fbbbd41-dfeb-4e02-9a50-653a2c2c03d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 29, 2015
Manufacturers
FDA
Prugen, Inc.
DUNS: 929922750
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 Code42546-700
Application NumberANDA077819
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metronidazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 29, 2015
FDA Product Classification
INGREDIENTS (8)
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
MetronidazoleActive
Quantity: 7.5 mg in 1 g
Code: 140QMO216E
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT