Naproxen Sodium (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Naproxen Sodium Tablets USP, 275 mg — Container Label

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

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Naproxen Sodium Tablets USP, 550 mg — Container Label

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

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NAPROXEN SODIUM
naproxen sodium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-494
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Naproxen sodium (NAPROXEN) NAPROXEN 275 mg
Inactive Ingredients
Ingredient Name Strength
magnesium stearate
CELLULOSE, MICROCRYSTALLINE
povidone
talc
Hypromellose 2910 (5 Mpa.S)
polyethylene glycol 400
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape OVAL (capsule shaped) Size 13mm
Flavor Imprint Code RDY;107
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-494-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-494-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-494-05 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-494-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078486 04/26/2016
NAPROXEN SODIUM
naproxen sodium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-495
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Naproxen sodium (NAPROXEN) NAPROXEN 550 mg
Inactive Ingredients
Ingredient Name Strength
magnesium stearate
CELLULOSE, MICROCRYSTALLINE
povidone
talc
Hypromellose 2910 (5 Mpa.S)
polyethylene glycol 400
titanium dioxide
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (capsule shaped) Size 19mm
Flavor Imprint Code RDY;1;08
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-495-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-495-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-495-05 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:43598-495-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078486 04/26/2016
Labeler — Dr. Reddy’s Laboratories Inc. (802315887)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited — FTO III 918608162 analysis (43598-494), manufacture (43598-494), analysis (43598-495), manufacture (43598-495)

Revised: 05/2021 Dr. Reddy’s Laboratories Inc.

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