FDA.reportPublic FDA data

Mekinist

Product NDC
0078-1161
11-digit product format
000781161
Labeler code
0078
Product ID
0078-1161_235e3bc1-099b-4587-9d72-b02fcc3387d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trametinib
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA217513
Marketing category
NDA
Marketing start
2023-03-16
Substance
TRAMETINIB DIMETHYL SULFOXIDE
Active strength
.05 mg/mL
Pharmacologic classes
Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mekinist
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMETINIB DIMETHYL SULFOXIDE.05 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBSB9VJ5TUT
Rxcui1425110, 1425116, 1425118, 2632560, 2632564, 1425104

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d187560-702b-563a-d8af-5e7debd67388Product name320231005
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-1161-47Mekinist90 mL in 1 BOTTLEPOWDER, FOR SOLUTION9035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-1161-47ML - Milliliter0078-1161a843281a-d766-4f56-affe-59ccf0b7065212023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-1161MEKINIST (TRAMETINIB) TABLET, FILM COATED MEKINIST (TRAMETINIB) POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]30Current NDC, 1 package rows20250412_0002ad27-779d-42ab-83b5-bc65453412a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2632564Mekinist 0.05 MG in 1 mL Oral SolutionPSN0002ad27-779d-42ab-83b5-bc65453412a135
1425110Mekinist 0.5 MG Oral TabletPSN0002ad27-779d-42ab-83b5-bc65453412a135
1425118Mekinist 2 MG Oral TabletPSN0002ad27-779d-42ab-83b5-bc65453412a135
2632560trametinib 0.05 MG in 1 mL Oral SolutionPSN0002ad27-779d-42ab-83b5-bc65453412a135
1425104trametinib 0.5 MG Oral TabletPSN0002ad27-779d-42ab-83b5-bc65453412a135
1425116trametinib 2 MG Oral TabletPSN0002ad27-779d-42ab-83b5-bc65453412a135
2632564trametinib 0.05 MG/ML Oral Solution [Mekinist]SBD0002ad27-779d-42ab-83b5-bc65453412a135
1425110trametinib 0.5 MG Oral Tablet [Mekinist]SBD0002ad27-779d-42ab-83b5-bc65453412a135
1425118trametinib 2 MG Oral Tablet [Mekinist]SBD0002ad27-779d-42ab-83b5-bc65453412a135
2632560trametinib 0.05 MG/ML Oral SolutionSCD0002ad27-779d-42ab-83b5-bc65453412a135
1425104trametinib 0.5 MG Oral TabletSCD0002ad27-779d-42ab-83b5-bc65453412a135
1425116trametinib 2 MG Oral TabletSCD0002ad27-779d-42ab-83b5-bc65453412a135
2632564Mekinist 0.05 MG per 1 ML Oral SolutionSY0002ad27-779d-42ab-83b5-bc65453412a135
2632564Mekinist 0.05 MG/ML Oral SolutionSY0002ad27-779d-42ab-83b5-bc65453412a135
1425110Mekinist 0.5 MG (as trametinib dimethyl sulfoxide 0.5635 MG) Oral TabletSY0002ad27-779d-42ab-83b5-bc65453412a135
1425110Mekinist 0.5 MG Oral TabletSY0002ad27-779d-42ab-83b5-bc65453412a135
1425118Mekinist 2 MG (as trametinib dimethyl sulfoxide 2.254 MG) Oral TabletSY0002ad27-779d-42ab-83b5-bc65453412a135
1425118Mekinist 2 MG Oral TabletSY0002ad27-779d-42ab-83b5-bc65453412a135
2632560trametinib 0.05 MG (equivalent to trametinib dimethyl sulfoxide) per 1 ML Oral SolutionSY0002ad27-779d-42ab-83b5-bc65453412a135
2632560trametinib 0.05 MG per 1 ML Oral SolutionSY0002ad27-779d-42ab-83b5-bc65453412a135
1425104trametinib 0.5 MG (as trametinib dimethyl sulfoxide 0.5635 MG) Oral TabletSY0002ad27-779d-42ab-83b5-bc65453412a135
1425116trametinib 2 MG (as trametinib dimethyl sulfoxide 2.254 MG) Oral TabletSY0002ad27-779d-42ab-83b5-bc65453412a135

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0078-1161-470007811614790 mL in 1 BOTTLE (0078-1161-47) 90 ml2023-03-16NoNoCurrent