FDA.reportPublic FDA data

Imatinib Mesylate

Product NDC
60505-2900
11-digit product format
605052900
Labeler code
60505
Product ID
60505-2900_0bbdf523-ac79-a5cf-7e2b-73426c1f268e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imatinib Mesylate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp
Application
ANDA079179
Marketing category
ANDA
Marketing start
2016-08-05
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Imatinib Mesylate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMATINIB MESYLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8A1O1M485B
Rxcui403878, 403879

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
60505-2900-0Imatinib Mesylate10 in 1 CARTONTABLET, FILM COATED1019
60505-2900-0Imatinib Mesylate10 in 1 BLISTER PACKTABLET, FILM COATED1019
60505-2900-1Imatinib Mesylate100 in 1 BOTTLETABLET, FILM COATED10019
60505-2900-3Imatinib Mesylate30 in 1 BOTTLETABLET, FILM COATED3019
60505-2900-8Imatinib Mesylate1000 in 1 BOTTLETABLET, FILM COATED100019
60505-2900-9Imatinib Mesylate90 in 1 BOTTLETABLET, FILM COATED9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2900-9EA - Each60505-29005f89e381-d89c-4fab-847c-f31f9999f2bb12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2900IMATINIB MESYLATE TABLET, FILM COATED [APOTEX CORP]17Current NDC, Legacy NDC, 6 package rows20240927_0291eca5-7a1d-4a79-30be-252224d96509.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403878imatinib mesylate 100 MG Oral TabletPSN0291eca5-7a1d-4a79-30be-252224d9650919
403879imatinib mesylate 400 MG Oral TabletPSN0291eca5-7a1d-4a79-30be-252224d9650919
403878imatinib 100 MG Oral TabletSCD0291eca5-7a1d-4a79-30be-252224d9650919
403879imatinib 400 MG Oral TabletSCD0291eca5-7a1d-4a79-30be-252224d9650919
403878imatinib (as imatinib mesylate) 100 MG Oral TabletSY0291eca5-7a1d-4a79-30be-252224d9650919
403879imatinib (as imatinib mesylate) 400 MG Oral TabletSY0291eca5-7a1d-4a79-30be-252224d9650919
403878imatinib mesylate 100 MG Oral TabletPSN7c037022-7fc8-4b6e-9db3-427206c572b47
403879imatinib mesylate 400 MG Oral TabletPSN7c037022-7fc8-4b6e-9db3-427206c572b47
403878imatinib 100 MG Oral TabletSCD7c037022-7fc8-4b6e-9db3-427206c572b47
403879imatinib 400 MG Oral TabletSCD7c037022-7fc8-4b6e-9db3-427206c572b47
403878imatinib (as imatinib mesylate) 100 MG Oral TabletSY7c037022-7fc8-4b6e-9db3-427206c572b47
403879imatinib (as imatinib mesylate) 400 MG Oral TabletSY7c037022-7fc8-4b6e-9db3-427206c572b47
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 startMarketing endSampleExclude flagStatus
60505-2900-06050529000010 BLISTER PACK in 1 CARTON (60505-2900-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2016-08-050000-00-00NoNoCurrent
60505-2900-160505290001100 TABLET, FILM COATED in 1 BOTTLE (60505-2900-1) 2016-08-050000-00-00NoNoCurrent
60505-2900-36050529000330 TABLET, FILM COATED in 1 BOTTLE (60505-2900-3) 2016-08-050000-00-00NoNoCurrent
60505-2900-8605052900081000 TABLET, FILM COATED in 1 BOTTLE (60505-2900-8) 2016-08-050000-00-00NoNoCurrent
60505-2900-96050529000990 TABLET, FILM COATED in 1 BOTTLE (60505-2900-9) 2016-08-050000-00-00NoNoCurrent