Label: IBUPROFEN tablet, film coated

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

Drug Label Information

Updated July 17, 2024

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  • HOW SUPPLIED

    NDC 68071-4009-7 Bottles of 15

    NDC 68071-4009-2 Botles of 20

    NDC 68071-4009-1 Bottles of 21

    NDC 68071-4009-3 Bottles of 30

    NDC 68071-4009-4 Bottles of 40

    NDC 68071-4009-5 Bottles of 50

    NDC 68071-4009-6 Bottles of 60

    NDC 68071-4009-9 Bottles of 90

  • 600mg Ibuprofen Package Label

    pdp

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68071-4009(NDC:49483-603)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code 122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-4009-715 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
    2NDC:68071-4009-220 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
    3NDC:68071-4009-121 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
    4NDC:68071-4009-330 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
    5NDC:68071-4009-440 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
    6NDC:68071-4009-550 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
    7NDC:68071-4009-660 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
    8NDC:68071-4009-990 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09079612/30/2015
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300repack(68071-4009)
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