FDA.reportPublic FDA data

Imatinib

Product NDC
43598-345
11-digit product format
435980345
Labeler code
43598
Product ID
43598-345_38a9944b-db90-72f2-3f0b-7767da490ae2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imatinib
Dosage form
TABLET
Route
ORAL
Labeler
Dr.Reddy's Laboratories Inc
Application
ANDA206547
Marketing category
ANDA
Marketing start
2018-08-13
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
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
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
43598-345-05Imatinib500 in 1 CONTAINERTABLET50018
43598-345-30Imatinib30 in 1 CONTAINERTABLET3018
43598-345-31Imatinib3 in 1 CARTONTABLET318
43598-345-31Imatinib10 in 1 BLISTER PACKTABLET1018
43598-345-90Imatinib90 in 1 CONTAINERTABLET9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-345-30EA - Each43598-3452e70cae9-d940-4ff3-a93c-f9cf77e90e9f12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-345IMATINIB TABLET [DR.REDDY'S LABORATORIES INC]17Current NDC, Legacy NDC, 5 package rows20240615_559dd8e5-11f9-70cd-3fb0-9f9eb8484a37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403878imatinib mesylate 100 MG Oral TabletPSN559dd8e5-11f9-70cd-3fb0-9f9eb8484a3718
403879imatinib mesylate 400 MG Oral TabletPSN559dd8e5-11f9-70cd-3fb0-9f9eb8484a3718
403878imatinib 100 MG Oral TabletSCD559dd8e5-11f9-70cd-3fb0-9f9eb8484a3718
403879imatinib 400 MG Oral TabletSCD559dd8e5-11f9-70cd-3fb0-9f9eb8484a3718
403878imatinib (as imatinib mesylate) 100 MG Oral TabletSY559dd8e5-11f9-70cd-3fb0-9f9eb8484a3718
403879imatinib (as imatinib mesylate) 400 MG Oral TabletSY559dd8e5-11f9-70cd-3fb0-9f9eb8484a3718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-345-0543598034505500 TABLET in 1 CONTAINER (43598-345-05) 500 tablet2018-08-130000-00-00NoNoCurrent
43598-345-304359803453030 TABLET in 1 CONTAINER (43598-345-30) 30 tablet2018-08-130000-00-00NoNoCurrent
43598-345-31435980345313 BLISTER PACK in 1 CARTON (43598-345-31) / 10 TABLET in 1 BLISTER PACK3 blister pack2020-09-150000-00-00NoNoCurrent
43598-345-904359803459090 TABLET in 1 CONTAINER (43598-345-90) 90 tablet2018-08-130000-00-00NoNoCurrent