Metronidazole
Approved
Approval ID
818dbe07-0267-4682-b171-5ab022ef9801
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2010
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6181
Application NumberANDA077819
Product Classification
M
Marketing Category
C73584
G
Generic Name
metronidazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2010
FDA Product Classification
INGREDIENTS (8)
METRONIDAZOLEActive
Quantity: 7.5 mg in 1 g
Code: 140QMO216E
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE CInactive
Code: 4Q93RCW27E
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT