Label: NAPROXEN tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 25, 2021

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  • INDICATIONS & USAGE

    Naproxen Tablets are indicated for:

    the relief of the signs and symptoms of:

    rheumatoid arthritis
    osteoarthritis
    ankylosing spondylitis
    polyarticular juvenile idiopathic arthritis
    tendonitis
    bursitis
    acute gout

    the management of:

    pain
    primary dysmenorrhea

  • PRINCIPAL DISPLAY PANEL

    Naproxen - Bottle

  • INGREDIENTS AND APPEARANCE
    NAPROXEN 
    naproxen tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80175-0436(NDC:50228-436)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN500 mg
    Product Characteristics
    Coloryellow (light yellow) Score2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code SG;436
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80175-0436-660 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21251703/01/2020
    Labeler - Central Packaging (117617671)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Packaging, LLC117617671repack(80175-0436)
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