Metronidazole
Metronidazole Topical Cream, 0.75% FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)
Approved
Approval ID
de4cb39f-cc6e-98fb-05e5-103f3aca2dad
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Cosette Pharmaceuticals, Inc.
DUNS: 116918230
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 Code0713-0633
Application NumberANDA077549
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metronidazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (8)
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METRONIDAZOLEActive
Quantity: 7.5 mg in 1 g
Code: 140QMO216E
Classification: ACTIB