Label: IBUPROFEN tablet, film coated

  • NDC Code(s): 43063-858-01, 43063-858-04, 43063-858-06, 43063-858-09, view more
    43063-858-10, 43063-858-12, 43063-858-15, 43063-858-18, 43063-858-20, 43063-858-21, 43063-858-24, 43063-858-28, 43063-858-30, 43063-858-40, 43063-858-60, 43063-858-82, 43063-858-90, 43063-858-93, 43063-858-94
  • Packager: PD-Rx 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 March 9, 2020

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

    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 4, 6, 9, 10, 12, 15, 18, 20, 21, 24, 28, 30, 40, 60, 90, 100, 180, 270 and 500.

  • 800 mg label

    43063858 label

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43063-858(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:43063-858-044 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/22/2018
    2NDC:43063-858-066 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/04/2019
    3NDC:43063-858-099 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/20/2019
    4NDC:43063-858-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/06/2018
    5NDC:43063-858-1212 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2018
    6NDC:43063-858-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2018
    7NDC:43063-858-1818 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2018
    8NDC:43063-858-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2018
    9NDC:43063-858-2121 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2018
    10NDC:43063-858-2424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/08/2019
    11NDC:43063-858-2828 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/24/2019
    12NDC:43063-858-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2018
    13NDC:43063-858-4040 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/03/2018
    14NDC:43063-858-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2018
    15NDC:43063-858-82500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/24/2020
    16NDC:43063-858-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2018
    17NDC:43063-858-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2019
    18NDC:43063-858-93180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2018
    19NDC:43063-858-94270 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09079612/30/2015
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(43063-858)