Imatinib Mesylate Tablets

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:48:26

Label at a glance#

Productimatinib mesylate
Active ingredientIMATINIB MESYLATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1394-9

Imatinib Mesylate Tablets, 100 mg

90 Tablets

Rx only

100 mg
100 mg

NDC 70771-1395-9

Imatinib Mesylate Tablets, 400 mg

90 Tablets

Rx only

400 mg
400 mg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210658-001IMATINIB MESYLATEIMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-08
A210658-002IMATINIB MESYLATEIMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A210658-001AB
A210658-002AB

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 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-0884e616aacf4f…
2026-09-14 22:38:342026-08A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-0884e616aacf4f…
2026-08-18 06:07:402026-07A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-08caaa826d4ba7…
2026-08-18 06:07:402026-07A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-084b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210658-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2020-04-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210658-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2020-04-08bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A210658-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A210658-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A210658-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210658-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210658-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210658-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210658-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210658-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210658-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210658-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210658-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210658-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210658-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210658-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210658-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210658-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210658-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210658-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210658-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210658-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210658-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210658-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210658-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210658-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210658-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210658-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210658-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210658-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210658-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210658-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210658-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210658-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210658-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210658-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210658-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210658-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210658-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210658-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210658-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210658-002AB1bb7c543d1eb4…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
db0f94b6-fac2-42c0-9430-0ecdcfcf6496f3296b6b-fa17-41fa-bdaa-90186f58684e2025-04-18Exact identifier
spl set id: f3296b6b-fa17-41fa-bdaa-90186f58684e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.