Home NDC 48433-050 Imatinib Mesylate
Product NDC 48433-050
11-digit product format 484330050
Labeler code 48433
Product ID 48433-050_4fa8a009-9b1c-3138-e063-6294a90a7320
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name imatinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Safecor Health, LLC
Application ANDA204644
Marketing category ANDA
Marketing start 2026-04-10
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 2027-12-31
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 A204644-001 IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 A204644-002 IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21
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 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204644-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2017-06-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204644-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2017-06-21 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 Mesylate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IMATINIB MESYLATE 400 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 48433-050-01 Imatinib Mesylate 1 in 1 BLISTER PACK TABLET, FILM COATED 1 2 48433-050-03 Imatinib Mesylate 30 in 1 CARTON TABLET, FILM COATED 30 2
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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 48433-050-01 48433005001 1 in 1 BLISTER PACK Historical 48433-050-03 48433005003 30 BLISTER PACK in 1 CARTON (48433-050-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-050-01) 30 blister pack 2026-04-10 No No Current