Naproxen (Page 8 of 8)

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count500 mg
6071610-597-53
12071610-597-70
18071610-597-80

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions -- TN
Cookeville, TN 38506
20210930JH

PRINCIPAL DISPLAY PANEL — 500 mg

NDC 71610-597 — Naproxen, USP 500 mg Tablets — Rx Only

Bottle Label 500 mg
(click image for full-size original)

NAPROXEN naproxen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-597(NDC:77771-436)
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
FERRIC OXIDE YELLOW
POVIDONE, UNSPECIFIED
MAGNESIUM STEARATE
Product Characteristics
Color yellow (light yellow) Score 2 pieces
Shape OVAL Size 16mm
Flavor Imprint Code SG;436
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71610-597-53 60 TABLET in 1 BOTTLE None
2 NDC:71610-597-70 120 TABLET in 1 BOTTLE None
3 NDC:71610-597-80 180 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212517 06/04/2021
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (71610-597)

Revised: 11/2021 Aphena Pharma Solutions — Tennessee, LLC

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