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 August 22, 2022

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  • 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)

    NDC 43063-858-04 Bottles of 4

    NDC 43063-858-06 Bottles of 6

    NDC 43063-858-09 Bottles of 9

    NDC 43063-858-10 Bottles of 10

    NDC 43063-858-12 Bottles of 12

    NDC 43063-858-15 Bottles of 15

    NDC 43063-858-18 Bottles of 18

    NDC 43063-858-20 Bottles of 20

    NDC 43063-858-21 Bottles of 21

    NDC 43063-858-24 Bottles of 24

    NDC 43063-858-28 Bottles of 28

    NDC 43063-858-30 Bottles of 30

    NDC 43063-858-40 Bottles of 40

    NDC 43063-858-60 Bottles of 60

    NDC 43063-858-90 Bottles of 90

    NDC 43063-858-01 Bottles of 100

    NDC 43063-858-93 Bottles of 180

    NDC 43063-858-94 Bottles of 270

    NDC 43063-858-82 Bottles of 500

  • 800 mg label

    image

  • 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)
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