Label: IBUPROFEN tablet, film coated

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

Drug Label Information

Updated July 7, 2022

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  • ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

    MEDGUIDE IBUPROFEN TABLETS
  • HOW SUPPLIED

    400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side)

     
    Bottles of 20 NDC 68788-7745-02
    Bottles of 28 NDC 68788-7745-08
    Bottles of 30 NDC 68788-7745-03
    Bottles of 50 NDC 68788-7745-05
    Bottles of 60 NDC 68788-7745-06
    Bottles of 90 NDC 68788-7745-09
    Bottles of 100 NDC 68788-7745-01

    Repackaged by Preferred Pharmaceuticals, Inc.

  • 400mg Ibuprofen

    Ibuprofen Tablets USP 400mg
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68788-7745(NDC:49483-602)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code 121
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-7745-220 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    2NDC:68788-7745-828 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    3NDC:68788-7745-330 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    4NDC:68788-7745-550 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    5NDC:68788-7745-660 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    6NDC:68788-7745-990 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    7NDC:68788-7745-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09079607/01/2020
    Labeler - Preferred Pharmaceuticals, Inc. (791119022)
    Registrant - Preferred Pharmaceuticals, Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals, Inc.791119022REPACK(68788-7745)