Naproxen (Page 9 of 9)

Package/Label Display Panel

NDC 0093-1005 -01

Naproxen Delayed-Release Tablets, USP 375 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

100 TABLETS

1

Package/Label Display Panel

NDC 0093-1006 -01

Naproxen Delayed-Release Tablets, USP 500 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

100 TABLETS

2

NAPROXEN naproxen tablet, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-1005 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN (NAPROXEN) NAPROXEN 375 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 INDIGOTINDISULFONATE SODIUM MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POVIDONE K90 PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE

Product Characteristics Color white (white to off-white) Score no score Shape OVAL (capsule-shaped) Size 15mm Flavor Imprint Code 93;5 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-1005-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE None 2 NDC:0093-1005-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075227 07/31/1998

NAPROXEN naproxen tablet, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-1006 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN (NAPROXEN) NAPROXEN 500 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 INDIGOTINDISULFONATE SODIUM MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POVIDONE K90 PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE

Product Characteristics Color white (white to off-white) Score no score Shape OVAL (capsule-shaped) Size 16mm Flavor Imprint Code 93;6 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-1006-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE None 2 NDC:0093-1006-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075227 07/29/1998

Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 07/2021 Teva Pharmaceuticals USA, Inc.