Imatinib mesylate

Product NDC
72485-202
11-digit product format
724850202
Labeler code
72485
Product ID
72485-202_f3d17411-8424-4c6d-b244-47f125f17f31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
imatinib mesylate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA208302
Marketing category
ANDA
Marketing start
2019-03-15
Substance
IMATINIB MESYLATE
Active strength
100 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
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
72485-202-90Imatinib mesylate90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-202-90EA - Each72485-2022138f5f5-8f5f-4090-957c-306077f32e7a12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-202IMATINIB MESYLATE TABLET, FILM COATED [ARMAS PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 1 package rows20190315_2e931c49-6c9f-41e2-a34b-5f01cd295b56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403878imatinib mesylate 100 MG Oral TabletPSN2e931c49-6c9f-41e2-a34b-5f01cd295b561
403878imatinib 100 MG Oral TabletSCD2e931c49-6c9f-41e2-a34b-5f01cd295b561
403878imatinib (as imatinib mesylate) 100 MG Oral TabletSY2e931c49-6c9f-41e2-a34b-5f01cd295b561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72485-202-907248502029090 TABLET, FILM COATED in 1 BOTTLE (72485-202-90) 2019-03-150000-00-00NoNoCurrent