FDA.reportPublic FDA data

Imatinib Mesylate

Product NDC
59651-241
11-digit product format
596510241
Labeler code
59651
Product ID
59651-241_4bffcf12-b3f8-44f9-9acb-4d6fcb6e50b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imatinib Mesylate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA212773
Marketing category
ANDA
Marketing start
2020-07-23
Substance
IMATINIB MESYLATE
Active strength
400 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 MESYLATE400 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
a07e1ba8-e0e6-1fcb-b05d-47e31d308a05Product name920230314
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-241-03Imatinib Mesylate10 in 1 BLISTER PACKTABLET, FILM COATED107
59651-241-03Imatinib Mesylate3 in 1 CARTONTABLET, FILM COATED37
59651-241-30Imatinib Mesylate30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-241IMATINIB MESYLATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6Current NDC, Legacy NDC, 3 package rows20240829_a4e409f7-20b4-4c80-8a6a-f95995ffad78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403878imatinib mesylate 100 MG Oral TabletPSNa4e409f7-20b4-4c80-8a6a-f95995ffad787
403879imatinib mesylate 400 MG Oral TabletPSNa4e409f7-20b4-4c80-8a6a-f95995ffad787
403878imatinib 100 MG Oral TabletSCDa4e409f7-20b4-4c80-8a6a-f95995ffad787
403879imatinib 400 MG Oral TabletSCDa4e409f7-20b4-4c80-8a6a-f95995ffad787
403878imatinib (as imatinib mesylate) 100 MG Oral TabletSYa4e409f7-20b4-4c80-8a6a-f95995ffad787
403879imatinib (as imatinib mesylate) 400 MG Oral TabletSYa4e409f7-20b4-4c80-8a6a-f95995ffad787

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-241-03596510241033 BLISTER PACK in 1 CARTON (59651-241-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2020-07-230000-00-00NoNoCurrent
59651-241-305965102413030 TABLET, FILM COATED in 1 BOTTLE (59651-241-30) 2020-07-230000-00-00NoNoCurrent