NDC 0078-0668

Mekinist

Trametinib

Mekinist is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Trametinib Dimethyl Sulfoxide.

• Product ID: 0078-0668_0a830197-c5c0-4299-a669-2abf0ea11c6a
• NDC: 0078-0668
• Product Type: Human Prescription Drug
• Proprietary Name: Mekinist
• Generic Name: Trametinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-03-17
• Marketing Category: NDA / NDA
• Application Number: NDA204114
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: TRAMETINIB DIMETHYL SULFOXIDE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0078-0668-15

30 TABLET, FILM COATED in 1 BOTTLE (0078-0668-15)

• Marketing Start Date: 2016-03-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0668-15 [00078066815]

Mekinist TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA204114
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-03-17

Drug Details

Active Ingredients

Ingredient	Strength
TRAMETINIB DIMETHYL SULFOXIDE	2 mg/1

OpenFDA Data

• SPL SET ID: 0002ad27-779d-42ab-83b5-bc65453412a1
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • BSB9VJ5TUT
• RxNorm Concept Unique ID - RxCUI:
  • 1425118
  • 1425104
  • 1425116
  • 1425110

Pharmacological Class

• Kinase Inhibitor [EPC]
• Protein Kinase Inhibitors [MoA]

NDC Crossover Matching brand name "Mekinist" or generic name "Trametinib"

NDC	Brand Name	Generic Name
0078-0666	Mekinist	trametinib
0078-0668	Mekinist	trametinib
0078-1105	Mekinist	trametinib
0078-1112	Mekinist	trametinib