Naproxen Sodium (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 550 mg

NDC 6878-7304
Rx only
Naproxen Sodium
Tablets USP
550 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
AUROBINDO

Repackaged By: Preferred Pharmaceuticals Inc.

Naproxen Sodium Tablets, USP 550mg
(click image for full-size original)
NAPROXEN SODIUM naproxen sodium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7304(NDC:65862-516)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 550 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C BLUE NO. 2
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 8000
POVIDONE K30
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (Dark Blue) Score 2 pieces
Shape CAPSULE (Modified Capsule Shaped) Size 19mm
Flavor Imprint Code T;22
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7304-4 14 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68788-7304-2 20 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68788-7304-3 30 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68788-7304-6 60 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:68788-7304-9 90 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:68788-7304-1 100 TABLET, FILM COATED in 1 BOTTLE None
7 NDC:68788-7304-8 120 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200629 01/03/2019
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-7304)

Revised: 07/2020 Preferred Pharmaceuticals Inc.

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