Naproxen (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

NDC 76282-340 -01

Naproxen
Tablets, USP

250 mg

PHARMACIST: Dispense the Medication Guide
provided separately to each patient.

EXELAN PHARMACEUTICALS, INC.

Rx Only 100 Tablets

275 mg
(click image for full-size original)

NDC 76282-341 -01

Naproxen Tablets, USP

375 mg

PHARMACIST: Dispense the Medication Guide
provided separately to each patient.

EXELAN PHARMACEUTICALS, INC.

Rx Only 100 Tablets

275 mg
(click image for full-size original)

NDC 76282-342 -01

Naproxen Tablets, USP

500 mg

PHARMACIST: Dispense the Medication Guide
provided separately to each patient.

EXELAN PHARMACEUTICALS, INC.

Rx Only 100 Tablets

550 mg
(click image for full-size original)
NAPROXEN naproxen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-340
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN (NAPROXEN) NAPROXEN 250 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
POVIDONE, UNSPECIFIED
FERRIC OXIDE YELLOW
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code I;G;340
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-340-01 100 TABLET in 1 BOTTLE None
2 NDC:76282-340-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091305 06/10/2016
NAPROXEN naproxen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-341
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
CROSCARMELLOSE SODIUM
POVIDONE, UNSPECIFIED
FERRIC OXIDE RED
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color pink Score no score
Shape OVAL Size 14mm
Flavor Imprint Code IG;341
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-341-01 100 TABLET in 1 BOTTLE None
2 NDC:76282-341-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091305 06/10/2016
NAPROXEN naproxen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-342
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
CROSCARMELLOSE SODIUM
POVIDONE, UNSPECIFIED
FERRIC OXIDE YELLOW
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color yellow Score 2 pieces
Shape OVAL Size 16mm
Flavor Imprint Code I;G;342
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76282-342-01 100 TABLET in 1 BOTTLE None
2 NDC:76282-342-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091305 06/10/2016
Labeler — Exelan Pharmaceuticals, Inc. (967795266)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceuticals Inc. 165104469 analysis (76282-340), analysis (76282-341), analysis (76282-342), manufacture (76282-340), manufacture (76282-341), manufacture (76282-342)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmaceuticals Inc. 080334903 analysis (76282-340), analysis (76282-341), analysis (76282-342), pack (76282-340), pack (76282-341), pack (76282-342)

Revised: 08/2020 Exelan Pharmaceuticals, Inc.

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