5/13
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.
Dispense in original bottle. Do not remove desiccant. Protect from moisture and light. Do not place medication in pill boxes.
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in Singapore
10000000109893 Rev. 5/13
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.
Dispense in original bottle. Do not remove desiccant. Protect from moisture and light. Do not place medication in pill boxes.
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in Singapore
10000000109894 Rev. 5/13
Mekinist
trametinib tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0849
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAMETINIB DIMETHYL SULFOXIDE (TRAMETINIB) TRAMETINIB 0.5 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
SILICON DIOXIDE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 9mm
Flavor Imprint Code GS;TFC
Contains
Packaging
Item Code Package Description
1 NDC:0173-0849-13 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204114 06/17/2013
Mekinist
trametinib tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0858
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAMETINIB DIMETHYL SULFOXIDE (TRAMETINIB) TRAMETINIB 1 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
SILICON DIOXIDE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code GS;LHE
Contains
Packaging
Item Code Package Desc
