METROGEL
Approved
Approval ID
bd3b62b6-4a80-495b-a1d3-d54eb15baf79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 31, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
metronidazole
PRODUCT DETAILS
NDC Product Code54868-3110
Application NumberNDA020208
Marketing CategoryC73594
Route of AdministrationVAGINAL
Effective DateMarch 31, 2011
Generic Namemetronidazole
INGREDIENTS (7)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
METRONIDAZOLEActive
Quantity: 7.5 mg in 1 g
Code: 140QMO216E
Classification: ACTIB
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT