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 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 Description
1 NDC:0173-0858-13 30 in 1 BOTTLE
 
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204114 06/17/2013