Label: SULFAMETHOXAZOLE AND TRIMETHOPRIM tablet

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

Drug Label Information

Updated May 6, 2014

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  • PRINCIPAL DISPLAY PANEL

    NDC: 51655-0186-28

    MFG: 53746-272-05

    SMZ/TMP

    800mg/160mg

    28 Tablets

    Rx only

    Dosage: See package insert

    Store at 68 to 77 degrees F.

    Store in a tight, light-resistance container. (See USP)

    Keep out of the reach of children.

    Each tablet contains: Sulfamethoxazole...800mg

    Trimethoprim...160mg

    Mfg by: Amneal Pharmaceuticals of NY 11788

    Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

    Lot# NW04100002

    Exp Date: 08/2015

    SMZ TMP 51655-0186

  • WARNINGS AND PRECAUTIONS

  • INGREDIENTS AND APPEARANCE
    SULFAMETHOXAZOLE AND TRIMETHOPRIM 
    sulfamethoxazole and trimethoprim tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-186(NDC:53746-272)
    Route of Administrationoral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFAMETHOXAZOLE (UNII: JE42381TNV) (SULFAMETHOXAZOLE - UNII:JE42381TNV) SULFAMETHOXAZOLE800 mg  in 28 
    TRIMETHOPRIM (UNII: AN164J8Y0X) (TRIMETHOPRIM - UNII:AN164J8Y0X) TRIMETHOPRIM160 mg  in 28 
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code IP272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-186-2828 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07689905/06/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-186)
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