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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
BSB9VJ5TUTTRAMETINIB DIMETHYL SULFOXIDE1187431-43-1TRAMETINIB DIMETHYL SULFOXIDE
33E86K87QNTRAMETINIB871700-17-3trametinib

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0078-1161-470007811614790 mL in 1 BOTTLE (0078-1161-47) 90 ml2023-03-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MekinistNovartis Pharmaceuticals Corporation2026-05-07HUMAN PRESCRIPTION DRUG LABEL35