Nuvessa
These highlights do not include all the information needed to use NUVESSA safely and effectively. See full prescribing information for NUVESSA. NUVESSA (metronidazole vaginal gel 1.3%) Initial U.S. Approval: 1963
Approved
Approval ID
3b6ff39d-f84b-43b3-9b07-c0521c6d7968
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2023
Manufacturers
FDA
Exeltis USA, Inc.
DUNS: 071170534
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 Code0642-7466
Application NumberNDA205223
Product Classification
M
Marketing Category
C73594
G
Generic Name
metronidazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (8)
METRONIDAZOLEActive
Quantity: 65 mg in 5 g
Code: 140QMO216E
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYCARBOPHILInactive
Code: W25LM17A4W
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT