NDC Code(s) : 52544-157-26
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Nuvessametronidazole GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52544-157
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METRONIDAZOLE(UNII: 140QMO216E)
(METRONIDAZOLE - UNII:140QMO216E) 		METRONIDAZOLE65 mg in 5 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
BENZYL ALCOHOL(UNII: LKG8494WBH)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
POLYCARBOPHIL(UNII: W25LM17A4W)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52544-157-261 in 1 CARTON
11 in 1 PACKAGE
15 g in 1 APPLICATOR Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205223 01/01/2015

PRINCIPAL DISPLAY PANEL

NDC 52544-157-26
NUVESSA™ 
(metronidazole vaginal gel 1.3%)
SINGLE-USE
Net Wt. 5 g

NDC 52544-157-26 NUVESSA™ (metronidazole vaginal gel 1.3%) SINGLE-USE Net Wt. 5 g