Imatinib Mesylate

Product NDC
60687-192
11-digit product format
606870192
Labeler code
60687
Product ID
60687-192_e0df2e29-34c1-d824-e053-2a95a90adbc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imatinib Mesylate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078340
Marketing category
ANDA
Marketing start
2016-02-15
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
60687-192-11EA - Each60687-192db55948d-1b20-40f8-902d-f1e0f69322ea12016-03-04
60687-192-21EA - Each60687-1923ebee323-7c97-40dd-a6b3-1c52176781d012016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-192IMATINIB MESYLATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]10Legacy NDC20250109_86d6a0c6-693b-4c33-bcfc-e174104384c6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-192-216068701922130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-192-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-192-11) 30 blister pack2016-02-150000-00-00NoNoCurrent