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

37 mg 100ct
(click image for full-size original)

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

500 mg 100ct
(click image for full-size original)

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.

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