NDC Code(s) : 57664-239-32, 57664-239-34
Packager : Caraco Pharmaceutical Laboratories, Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NITROFURANTOIN NITROFURANTOIN SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-239
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROFURANTOIN(UNII: 927AH8112L)
(NITROFURANTOIN - UNII:927AH8112L) 		NITROFURANTOIN25 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
GLYCERIN(UNII: PDC6A3C0OX)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
METHYLPARABEN(UNII: A2I8C7HI9T)
FRUIT(UNII: C2AIY4ERZC)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SORBITOL(UNII: 506T60A25R)
SUCRALOSE(UNII: 96K6UQ3ZD4)
Product Characteristics
Color YELLOW (lemon yellow) Score
Shape Size
Flavor FRUIT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57664-239-32240 mL in 1 BOTTLE, PLASTIC
2NDC:57664-239-34480 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201355 03/04/2012

PRINCIPAL DISPLAY PANEL

NDC 57664-239-32

Nitrofurantoin Oral Suspension, USP

25 mg/5 mL

FOR ORAL USE ONLY

URINARY TRACT ANTIBACTERIAL

Rx Only

240 mL

Caraco Pharmaceutical Laboratories, Ltd.
nitrofurantoin-labe