NAPROXEN DELAYED RELEASE TABLET, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS]

NAPROXEN DELAYED RELEASE TABLET, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS]
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NDC 51655-628-52
Set ID c66b0b05-84b4-4f0c-82b2-f0c386f6f64f
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Northwind Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number ANDA091432
  • 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

    Naproxen 51655-628

  • WARNINGS AND PRECAUTIONS

  • INGREDIENTS AND APPEARANCE
    NAPROXEN DELAYED RELEASE 
    naproxen delayed release tablet, delayed release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-628(NDC:31722-339)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN500 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code I;11
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-628-5230 in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09143205/16/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-628)

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