Label: IBUPROFEN tablet, film coated

  • NDC Code(s): 68788-7079-1, 68788-7079-2, 68788-7079-3, 68788-7079-4, view more
    68788-7079-5, 68788-7079-6, 68788-7079-7, 68788-7079-8, 68788-7079-9
  • Packager: Preferred Pharmaceuticals Inc.
  • This is a repackaged label.
  • Source NDC Code(s): 49483-604
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 7, 2022

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

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

    MEDGUIDE IBUPROFEN TABLETS
  • HOW SUPPLIED

  • HOW SUPPLIED

    800 mg (white to off-white, capsule shaped, biconvex, film-coated​ tablets debossed with ‘123’ on one side and plain on other side)

     
    Bottles of 14 NDC 68788-7079-4

    Repackaged By: Preferred Pharmaceuticals Inc.

  • 800mg LABEL

    Ibuprofen Tablets USP 800mg
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68788-7079(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)  
    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
    ShapeCAPSULESize19mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-7079-414 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
    2NDC:68788-7079-220 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
    3NDC:68788-7079-721 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
    4NDC:68788-7079-330 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
    5NDC:68788-7079-550 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
    6NDC:68788-7079-660 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
    7NDC:68788-7079-990 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
    8NDC:68788-7079-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
    9NDC:68788-7079-8120 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09079606/17/2020
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022REPACK(68788-7079)