Mekinist

Product NDC
0078-0668
11-digit product format
000780668
Labeler code
0078
Product ID
0078-0668_58ebc072-df4c-4e0e-86ff-5c992a0ab1c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trametinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA204114
Marketing category
NDA
Marketing start
2016-03-17
Marketing end
0000-00-00
Substance
TRAMETINIB DIMETHYL SULFOXIDE
Active strength
2 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0668-15EA - Each0078-06688e7322ec-2285-49b4-bda6-9406dd3c263212016-05-16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0668-150007806681530 TABLET, FILM COATED in 1 BOTTLE (0078-0668-15) 2016-03-170000-00-00NoNoCurrent