Imatinib Mesylate

Product NDC
50268-426
11-digit product format
502680426
Labeler code
50268
Product ID
50268-426_d5ddafe4-4a9b-1881-e053-2a95a90ae245
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imatinib Mesylate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA079179
Marketing category
ANDA
Marketing start
2017-08-24
Marketing end
0000-00-00
Substance
IMATINIB MESYLATE
Active strength
100 mg/1
Pharmacologic classes
Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]
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
50268-426-11EA - Each50268-426c997df4e-5c6b-40ea-8ccf-3373762fd26212018-01-12
50268-426-12EA - Each50268-426dce8173f-6653-4de0-823e-cc89665cc0ae12018-01-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-426-125026804261220 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-426-12) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-426-11) 20 blister pack2017-08-240000-00-00NoNoCurrent