Home NDC 43598-344 Imatinib
Product NDC 43598-344
11-digit product format 435980344
Labeler code 43598
Product ID 43598-344_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 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 2026-12-31
Current FDA listing Yes 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-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 · 82 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 2026-02-19 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…2022-03-09 01:35 UTC 2022-03 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206547-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2018-08-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206547-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2018-08-13 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Imatinib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IMATINIB MESYLATE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8A1O1M485B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403878 Internal RxNorm lookup 403879 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 Current NDC, Legacy NDC, 5 package rows 20240615_559dd8e5-11f9-70cd-3fb0-9f9eb8484a37.zip
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.
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 43598-344-10 43598034410 1000 TABLET in 1 CONTAINER (43598-344-10) 1000 tablet 2018-08-13 0000-00-00 No No Current 43598-344-30 43598034430 30 TABLET in 1 CONTAINER (43598-344-30) 30 tablet 2018-08-13 0000-00-00 No No Current 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 43598-344-90 43598034490 90 TABLET in 1 CONTAINER (43598-344-90) 90 tablet 2018-08-13 0000-00-00 No No Current