Label: SITAGLIPTIN - METFORMIN tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated April 14, 2023

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  • CONTRAINDICATIONS

    History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. [See Warnings and Precautions (5.4); Adverse Reactions (6.2).]

  • PRINCIPAL DISPLAY PANEL

    SITAGLIPTIN/METFORMIN 50/850MGSITAGLIPTIN/METFORMIN 50/850MG

  • INGREDIENTS AND APPEARANCE
    SITAGLIPTIN - METFORMIN 
    sitagliptin - metformin tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:82922-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METFORMIN (UNII: 9100L32L2N) (METFORMIN - UNII:9100L32L2N) METFORMIN850 mg
    SITAGLIPTIN (UNII: QFP0P1DV7Z) (SITAGLIPTIN - UNII:QFP0P1DV7Z) SITAGLIPTIN50 mg
    Product Characteristics
    ColorredScoreno score
    ShapeBULLETSize10mm
    FlavorImprint Code 50850
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82922-100-0128 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2023
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only04/14/2023
    Labeler - Truemed Group LLC (004154534)
    Establishment
    NameAddressID/FEIBusiness Operations
    Truemed Group LLC004154534pack(82922-100) , label(82922-100)
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