Imatinib Mesylate

Product NDC
0054-0249
11-digit product format
000540249
Labeler code
0054
Product ID
0054-0249_6bee6fa5-7883-4e39-b381-e2ed52f566e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imatinib Mesylate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA207586
Marketing category
ANDA
Marketing start
2018-09-28
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0054-0249DDiscontinued by firm2026-08-07
excluded packagepackage0054-02490054-0249-12DDiscontinued by firm2026-08-07
excluded packagepackage0054-02490054-0249-13DDiscontinued by firm2026-08-07
excluded packagepackage0054-02490054-0249-22DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0054-0249-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0054-0249-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0054-0249-22d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0054-0249-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0054-0249-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0054-0249-22f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0054-0249-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0054-0249-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0054-0249-222ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0054-0249-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0054-0249-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0054-0249-22a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0054-0249-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0054-0249-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0054-0249-22cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0054-0249-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0054-0249-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0054-0249-22cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0054-0249-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0054-0249-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0054-0249-22302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-0249-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-0249-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-0249-22ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-0249-130efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-0249-120efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-0249-220efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-0249-13ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-0249-12ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-0249-22ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-0249-13367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-0249-12367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-0249-22367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-0249-13557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-0249-12557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-0249-22557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207586-001IMATINIB MESYLATEIMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2018-07-13
A207586-002IMATINIB MESYLATEIMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2018-07-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2018-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2018-07-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2018-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2018-07-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2018-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2018-07-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2018-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2018-07-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2018-07-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2018-07-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2018-07-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2018-07-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2018-07-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2018-07-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2018-07-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2018-07-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2018-07-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2018-07-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2018-07-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2018-07-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2018-07-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2018-07-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2018-07-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2018-07-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2018-07-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2018-07-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORAL2018-07-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORAL2018-07-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2018-07-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2018-07-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2018-07-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2018-07-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2018-07-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2018-07-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2018-07-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2018-07-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2018-07-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2018-07-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207586-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2018-07-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A207586-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2018-07-13782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207586-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207586-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207586-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207586-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207586-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207586-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207586-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207586-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207586-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207586-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207586-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207586-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207586-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207586-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207586-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A207586-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207586-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A207586-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207586-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207586-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207586-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A207586-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207586-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207586-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207586-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207586-002AB1ea99ee380514…
2023-12-20 04:57 UTC2023-12A207586-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A207586-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207586-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207586-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207586-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207586-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207586-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207586-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207586-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207586-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207586-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A207586-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207586-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A207586-002AB13bdfa0b2c4d7…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0249-13EA - Each0054-024991798baa-fd85-4eda-9b73-4033e824d34012018-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0249-12000540249123 BLISTER PACK in 1 CARTON (0054-0249-12) > 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2018-09-280000-00-00NoNoCurrent
0054-0249-130005402491330 TABLET, FILM COATED in 1 BOTTLE (0054-0249-13) 2018-09-280000-00-00NoNoCurrent
0054-0249-220005402492290 TABLET, FILM COATED in 1 BOTTLE (0054-0249-22) 2018-09-280000-00-00NoNoCurrent