IMATINIB MESYLATE

Product NDC
51991-377
11-digit product format
519910377
Labeler code
51991
Product ID
51991-377_33a6c95d-ec44-461c-9eef-a771aa0981ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IMATINIB MESYLATE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA205990
Marketing category
ANDA
Marketing start
2019-02-08
Marketing end
2023-06-30
Substance
IMATINIB MESYLATE
Active strength
400 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-377-33EA - Each51991-3771e01ff8f-5a16-49fc-a091-33fa90f9444012019-10-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51991-377-0551991037705500 TABLET, COATED in 1 BOTTLE (51991-377-05) 2019-02-082023-06-30NoNoCurrent
51991-377-335199103773330 TABLET, COATED in 1 BOTTLE (51991-377-33) 2019-02-082023-06-30NoNoCurrent
51991-377-905199103779090 TABLET, COATED in 1 BOTTLE (51991-377-90) 2019-02-082023-06-30NoNoCurrent