Label: MEKINIST- trametinib tablet, film coated

  • NDC Code(s): 12064-015-00, 12064-016-00, 12064-017-00
  • Packager: GlaxoSmithKline Manufacturing SpA
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT

Drug Label Information

Updated November 14, 2017

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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    NDC 0173-0849-13

    Mekinist®

    (trametinib) Tablets

    0.5 mg*

    Rx only

    30 Tablets

    *Each tablet contains 0.5635 mg trametinib dimethyl sulfoxide equivalent to 0.5 mg of trametinib.

    Dosage: See accompanying prescribing information.

    Store refrigerated at 2° and 8°C (36° to 46°F).

    Do not freeze.

    Do not use if printed safety seal under cap is broken or missing.

    Dispense in original bottle. Do not remove desiccant. Protect from moisture and light. Do not place medication in pill boxes.

    GlaxoSmithKline

    RTP, NC 27709

    Made in Singapore

     
    10000000124168 Rev. 2/14
    Mekinist 0.5mg 30 count label
    Close
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    NDC 0173-0858-13

    Mekinist®

    (trametinib) Tablets

    1 mg*

    Rx only

    30 Tablets

    *Each tablet contains 1.127 mg trametinib dimethyl sulfoxide equivalent to 1 mg of trametinib.

    Dosage: See accompanying prescribing information.

    Store refrigerated at 2° and 8°C (36° to 46°F).

    Do not freeze.

    Do not use if printed safety seal under cap is broken or missing.

    Dispense in original bottle. Do not remove desiccant. Protect from moisture and light. Do not place medication in pill boxes.

    GlaxoSmithKline

    RTP, NC 27709

    Made in Singapore

     
    10000000124169 Rev. 3/14
    Mekinist 1mg 30 count label
    Close
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    NDC 0173-0848-13

    Mekinist®

    (trametinib) Tablets

    2 mg*

    Rx only

    30 Tablets

    *Each tablet contains 2.254 mg trametinib dimethyl sulfoxide equivalent to 2 mg of trametinib.

    Dosage: See accompanying prescribing information.

    Store refrigerated at 2° and 8°C (36° to 46°F).

    Do not freeze.

    Do not use if printed safety seal under cap is broken or missing.

    Dispense in original bottle. Do not remove desiccant. Protect from moisture and light. Do not place medication in pill boxes.

    GlaxoSmithKline

    RTP, NC 27709

    Made in Singapore

     
    10000000124203 Rev. 3/14
    Mekinist 2mg 30 count label
    Close
  • INGREDIENTS AND APPEARANCE
    MEKINIST 
    trametinib tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12064-015
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRAMETINIB DIMETHYL SULFOXIDE (UNII: BSB9VJ5TUT) (TRAMETINIB - UNII:33E86K87QN) TRAMETINIB 0.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    Color YELLOW Score no score
    Shape OVAL Size 9mm
    Flavor Imprint Code GS;TFC
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12064-015-00 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/17/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Approved Drug Product Manufactured Under Contract NDA204114 06/17/2013
    MEKINIST 
    trametinib tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12064-016
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRAMETINIB DIMETHYL SULFOXIDE (UNII: BSB9VJ5TUT) (TRAMETINIB - UNII:33E86K87QN) TRAMETINIB 1 mg
    Inactive Ingredients
    Ingredient Name Strength
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code GS;LHE
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12064-016-00 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/17/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Approved Drug Product Manufactured Under Contract NDA204114 06/17/2013
    MEKINIST 
    trametinib tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12064-017
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRAMETINIB DIMETHYL SULFOXIDE (UNII: BSB9VJ5TUT) (TRAMETINIB - UNII:33E86K87QN) TRAMETINIB 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code GS;HMJ
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12064-017-00 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/17/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Approved Drug Product Manufactured Under Contract NDA204114 06/17/2013
    Labeler - GlaxoSmithKline Manufacturing SpA (338471078)
    Close