NDC Code(s) : 0603-1481-49, 0603-1481-58
Packager : Par Pharmaceutical

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NystatinNystatin SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-1481
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NYSTATIN(UNII: BDF1O1C72E)
(NYSTATIN - UNII:BDF1O1C72E) 		NYSTATIN100000 [USP'U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
GLYCERIN(UNII: PDC6A3C0OX)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0603-1481-491 in 1 CARTON 28/06/2005
160 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product
2NDC:0603-1481-58473 mL in 1 BOTTLE Type 0: Not a Combination Product28/06/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065148 06/28/2005 04/30/2019

PRINCIPAL DISPLAY PANEL

This is an image of the label for 60 mL Nystatin Oral Suspension, USP.

PRINCIPAL DISPLAY PANEL

This is an image of the label for 473 mL Nystatin Oral Suspension, USP.

PRINCIPAL DISPLAY PANEL

This is an image of the carton for Nystatin Oral Suspension.