FDA.reportPublic FDA data

imatinib mesylate

Product NDC
47335-475
11-digit product format
473350475
Labeler code
47335
Product ID
47335-475_ad13dbca-474d-4492-9c25-e0e175143d8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
imatinib mesylate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078340
Marketing category
ANDA
Marketing start
2016-02-01
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
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 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
a07e1ba8-e0e6-1fcb-b05d-47e31d308a05Product name920230314
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47335-475-132020-08-05C16284748780-1ab0e2407-33d6-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001
47335-475-832020-08-05C16284748780-1ab0e2407-33d6-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001
47335-475-882020-08-05C16284748780-1ab0e2407-33d6-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001
47335-475-132020-07-22C16284748780-1ab0e2407-33d6-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001
47335-475-832020-07-22C16284748780-1ab0e2407-33d6-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001
47335-475-882020-07-22C16284748780-1ab0e2407-33d6-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-475-13imatinib mesylate500 in 1 BOTTLETABLET, FILM COATED50026
47335-475-64imatinib mesylate10 in 1 BLISTER PACKTABLET, FILM COATED1026
47335-475-64imatinib mesylate3 in 1 CARTONTABLET, FILM COATED326
47335-475-83imatinib mesylate30 in 1 BOTTLETABLET, FILM COATED3026
47335-475-88imatinib mesylate100 in 1 BOTTLETABLET, FILM COATED10026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-475-83EA - Each47335-475b19b7e44-0b33-4ece-a64f-fa2866dc6b2512016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-475IMATINIB MESYLATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]26Current NDC, Legacy NDC, 5 package rows20220916_07764bf9-21b4-4e32-9d7e-e348f8e4291f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403878imatinib mesylate 100 MG Oral TabletPSN07764bf9-21b4-4e32-9d7e-e348f8e4291f26
403879imatinib mesylate 400 MG Oral TabletPSN07764bf9-21b4-4e32-9d7e-e348f8e4291f26
403878imatinib 100 MG Oral TabletSCD07764bf9-21b4-4e32-9d7e-e348f8e4291f26
403879imatinib 400 MG Oral TabletSCD07764bf9-21b4-4e32-9d7e-e348f8e4291f26
403878imatinib (as imatinib mesylate) 100 MG Oral TabletSY07764bf9-21b4-4e32-9d7e-e348f8e4291f26
403879imatinib (as imatinib mesylate) 400 MG Oral TabletSY07764bf9-21b4-4e32-9d7e-e348f8e4291f26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-475-1347335047513500 TABLET, FILM COATED in 1 BOTTLE (47335-475-13) 2016-02-010000-00-00NoNoCurrent
47335-475-64473350475643 BLISTER PACK in 1 CARTON (47335-475-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2016-02-010000-00-00NoNoCurrent
47335-475-834733504758330 TABLET, FILM COATED in 1 BOTTLE (47335-475-83) 2016-02-010000-00-00NoNoCurrent
47335-475-8847335047588100 TABLET, FILM COATED in 1 BOTTLE (47335-475-88) 2016-02-010000-00-00NoNoCurrent