FDA.reportPublic FDA data

Imatinib Mesylate

Product NDC
60687-882
11-digit product format
606870882
Labeler code
60687
Product ID
60687-882_2e836e9c-5571-8d0b-e063-6394a90aa196
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imatinib Mesylate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA079179
Marketing category
ANDA
Marketing start
2025-02-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Imatinib Mesylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMATINIB MESYLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8A1O1M485B
Rxcui403878

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d2ca280-d5c0-49b4-9bbd-0191c7e031beProduct name120250724
a07e1ba8-e0e6-1fcb-b05d-47e31d308a05Product name920230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-882-11Imatinib Mesylate1 in 1 BLISTER PACKTABLET, FILM COATED12
60687-882-21Imatinib Mesylate30 in 1 CARTONTABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-882-11EA - Each60687-882c157aed5-80bd-4f5b-9930-e30329fdc56d12025-02-10
60687-882-21EA - Each60687-88299865a12-20de-4ffa-8593-40a1cb5a89b912025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-882IMATINIB MESYLATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2Current NDC, 2 package rows20250223_6e7ed4ef-24e3-4545-9a99-2e34c946e8e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403878imatinib mesylate 100 MG Oral TabletPSN6e7ed4ef-24e3-4545-9a99-2e34c946e8e72
403878imatinib 100 MG Oral TabletSCD6e7ed4ef-24e3-4545-9a99-2e34c946e8e72
403878imatinib (as imatinib mesylate) 100 MG Oral TabletSY6e7ed4ef-24e3-4545-9a99-2e34c946e8e72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-882-11606870882111 in 1 BLISTER PACKHistorical
60687-882-216068708822130 BLISTER PACK in 1 CARTON (60687-882-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-882-11) 30 blister pack2025-02-19NoNoHistorical