Label: IBUPROFEN tablet, film coated

  • NDC Code(s): 43063-867-01, 43063-867-04, 43063-867-06, 43063-867-10, view more
    43063-867-15, 43063-867-20, 43063-867-21, 43063-867-24, 43063-867-30, 43063-867-40, 43063-867-60, 43063-867-82, 43063-867-90
  • Packager: PD-Rx Pharmaceuticals, Inc.
  • This is a repackaged label.
  • Source NDC Code(s): 49483-603
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 8, 2020

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

    MEDGUIDE IBUPROFEN TABLETS

  • HOW SUPPLIED

    600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 4, 6, 10, 15, 20, 21, 24, 30, 40, 60, 90, 100 and 500.

  • 600 mg

    image

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43063-867(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:43063-867-044 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/31/2019
    2NDC:43063-867-066 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2018
    3NDC:43063-867-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/2018
    4NDC:43063-867-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/05/2018
    5NDC:43063-867-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/05/2018
    6NDC:43063-867-2121 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/11/2018
    7NDC:43063-867-2424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/12/2018
    8NDC:43063-867-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/12/2018
    9NDC:43063-867-4040 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/2018
    10NDC:43063-867-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/05/2018
    11NDC:43063-867-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/11/2018
    12NDC:43063-867-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/11/2018
    13NDC:43063-867-82500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/24/2020
    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(43063-867)
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