NDC Code(s) : 55289-445-12, 55289-445-15, 55289-445-20, 55289-445-21, 55289-445-28, 55289-445-30, 55289-445-60
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NaproxenNaproxen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55289-445(NDC:0143-1346)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN(UNII: 57Y76R9ATQ)
(NAPROXEN - UNII:57Y76R9ATQ) 		NAPROXEN250 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color white (WHITE) Score no score
Shape ROUND (ROUND) Size 8 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55289-445-1212 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/01/2011
2NDC:55289-445-1515 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/01/2011
3NDC:55289-445-2020 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/01/2011
4NDC:55289-445-2121 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/01/2011
5NDC:55289-445-2828 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/01/2011
6NDC:55289-445-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/01/2011
7NDC:55289-445-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076494 01/14/2004

PRINCIPAL DISPLAY PANEL


Naproxen Tablets, USP
250 mg
100 Tablets
Rx Only

55289445 Label