MEKINIST- trametinib tablet, film coated 
GlaxoSmithKline Manufacturing SpA

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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

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

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
MEKINIST 
trametinib tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:12064-015
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAMETINIB DIMETHYL SULFOXIDE (UNII: BSB9VJ5TUT) (TRAMETINIB - UNII:33E86K87QN) TRAMETINIB0.5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOWScoreno score
ShapeOVALSize9mm
FlavorImprint Code GS;TFC
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12064-015-0030 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA20411406/17/2013
MEKINIST 
trametinib tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:12064-016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAMETINIB DIMETHYL SULFOXIDE (UNII: BSB9VJ5TUT) (TRAMETINIB - UNII:33E86K87QN) TRAMETINIB1 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScoreno score
ShapeROUNDSize7mm
FlavorImprint Code GS;LHE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12064-016-0030 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA20411406/17/2013
MEKINIST 
trametinib tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:12064-017
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAMETINIB DIMETHYL SULFOXIDE (UNII: BSB9VJ5TUT) (TRAMETINIB - UNII:33E86K87QN) TRAMETINIB2 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINKScoreno score
ShapeROUNDSize8mm
FlavorImprint Code GS;HMJ
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12064-017-0030 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA20411406/17/2013
Labeler - GlaxoSmithKline Manufacturing SpA (338471078)

Revised: 11/2017
 
GlaxoSmithKline Manufacturing SpA