Label: NAPROXEN DELAYED RELEASE tablet, delayed release
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Contains inactivated NDC Code(s)
NDC Code(s): 51655-628-52 - Packager: Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 31722-339
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 3, 2014
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PRINCIPAL DISPLAY PANEL
NDC: 51655-628-52
MFG: 31722-339-01
Naproxen Delayed Release 500mg
30 tablets
Rx only
Lot#:
Exp. Date:
Each tablet contains naproxen 500 mg
Dosage: See package insert
Store at 68 to 77 degrees F.
Store in a tight, light-resistant container (See USP). Keep out of the reach of children.
Mfg by: InvaGen Pharmaceuticals, Inc Hauppage, NY 11788 for Camber Pharmaceuticals, Piscataway, NJ 08854
Lot# Exp:
Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256
- WARNINGS AND PRECAUTIONS
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INGREDIENTS AND APPEARANCE
NAPROXEN DELAYED RELEASE
naproxen delayed release tablet, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-628(NDC:31722-339) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN 500 mg Product Characteristics Color white Score no score Shape OVAL Size 16mm Flavor Imprint Code I;11 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51655-628-52 30 in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091432 05/16/2014 Labeler - Northwind Pharmaceuticals (036986393) Registrant - Northwind Pharmaceuticals (036986393) Establishment Name Address ID/FEI Business Operations Northwind Pharmaceuticals 036986393 repack(51655-628)