Home NDC 43598-344-31 Imatinib
Product NDC 43598-344
Requested package NDC 43598-344-31
11-digit product format 435980344
Labeler code 43598
Product ID 43598-344_d905cdb0-eca9-d4f8-d875-08cb6fd75327
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
Marketing end 0000-00-00
Substance IMATINIB MESYLATE
Active strength 100 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206547-001 IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 A206547-002 IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-344 IMATINIB TABLET [DR.REDDY'S LABORATORIES INC] 17 Legacy NDC, 5 package rows 20240615_559dd8e5-11f9-70cd-3fb0-9f9eb8484a37.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43598-344-31 43598034431 3 BLISTER PACK in 1 CARTON (43598-344-31) > 10 TABLET in 1 BLISTER PACK 3 blister pack 2020-09-15 0000-00-00 No No Current