Label: IBUPROFEN tablet, film coated

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

Drug Label Information

Updated October 9, 2019

If you are a consumer or patient please visit this version.

  • HOW SUPPLIED

    NDC 68071-3362-0 Bottles of 12

    NDC 68071-3362-5 Bottles of 15

    NDC 68071-3362-2 Bottles of 20

    NDC 68071-3362-2 Bottles of 21

    NDC 68071-3362-3 Bottles of 30

    NDC 68071-3362-4 Bottles of 40

    NDC 68071-3362-6 Bottles of 60

    NDC 68071-3362-9 Bottles of 90

  • 800mg Ibuprofen Package Label

    PDP

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68071-3362(NDC:49483-604)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN800 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
    ShapeCAPSULESize19mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-3362-515 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2017
    2NDC:68071-3362-012 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2017
    3NDC:68071-3362-220 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2017
    4NDC:68071-3362-121 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2017
    5NDC:68071-3362-330 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2017
    6NDC:68071-3362-440 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2017
    7NDC:68071-3362-660 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2017
    8NDC:68071-3362-990 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2017
    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(68071-3362)