NDC Code(s) : 0480-0951-01, 0480-0952-58, 0480-0953-56
Packager : Teva Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Naproxen Sodiumnaproxen sodium TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-0951
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM(UNII: 9TN87S3A3C)
(NAPROXEN - UNII:57Y76R9ATQ) 		NAPROXEN375 mg
Product Characteristics
Color white Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code Andrx;825
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0480-0951-01100 in 1 BOTTLE Type 0: Not a Combination Product11/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075416 11/01/2022
Naproxen sodiumnaproxen sodium TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-0952
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM(UNII: 9TN87S3A3C)
(NAPROXEN - UNII:57Y76R9ATQ) 		NAPROXEN500 mg
Product Characteristics
Color white Score no score
Shape OVAL (capsule-shaped) Size 17 mm
Flavor Imprint Code Andrx;826
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0480-0952-5875 in 1 BOTTLE Type 0: Not a Combination Product11/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075416 11/01/2022
Naproxen Sodiumnaproxen sodium TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-0953
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM(UNII: 9TN87S3A3C)
(NAPROXEN - UNII:57Y76R9ATQ) 		NAPROXEN750 mg
Product Characteristics
Color white Score no score
Shape OVAL (capsule-shaped) Size 22 mm
Flavor Imprint Code A750
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0480-0953-5630 in 1 BOTTLE Type 0: Not a Combination Product11/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075416 11/01/2022

LABELER - Teva Pharmaceuticals, Inc.(022629579)

PRINCIPAL DISPLAY PANEL

NDC 0480-0951-01

Naproxen Sodium Extended-Release Tablets

375 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

100 Tablets

1

PRINCIPAL DISPLAY PANEL

NDC 0480-0952-58

Naproxen Sodium Extended-Release Tablets

500 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

75 Tablets

1

PRINCIPAL DISPLAY PANEL

NDC 0480-0953-56

Naproxen Sodium Extended-Release Tablets

750 mg*

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Tablets

1