Imatinib Mesylate

Product NDC
50268-427
11-digit product format
502680427
Labeler code
50268
Product ID
50268-427_e0c93637-3e5c-36e1-e053-2995a90ab700
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
400 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
50268-427-11EA - Each50268-4277cdb83c0-ef9f-4651-8aab-5648f664f6b912018-01-12
50268-427-12EA - Each50268-427920a706b-e8a6-4021-8380-60f07e0fc91b12018-01-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-427-125026804271220 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-427-12) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-427-11) 20 blister pack2017-08-240000-00-00NoNoCurrent