Metronidazole
Metronidazole Topical Gel USP, 0.75%
Approved
Approval ID
ae578c2d-7ea2-4e18-bad8-c1da2429b7cb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code42254-069
Application NumberANDA077547
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateSeptember 21, 2009
Generic NameMetronidazole
INGREDIENTS (8)
METRONIDAZOLEActive
Quantity: 7.5 mg in 1 g
Code: 140QMO216E
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT