Home NDC 72485-203 Imatinib mesylate
Product NDC 72485-203
11-digit product format 724850203
Labeler code 72485
Product ID 72485-203_2e636646-af84-4711-84b4-9092bb51ca8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name imatinib mesylate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Armas Pharmaceuticals Inc.
Application ANDA208302
Marketing category ANDA
Marketing start 2019-03-15
Substance IMATINIB MESYLATE
Active strength 400 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
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 42 .
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 A208302-001 IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 A208302-002 IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17
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 · 84 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 2026-08-18 06:07:40 2026-07 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208302-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2019-01-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208302-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2019-01-17 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Imatinib mesylate
Brand name suffix 400 mg
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 72485-203-30 Imatinib mesylate400 mg 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72485-203 IMATINIB MESYLATE 400 MG (IMATINIB MESYLATE) TABLET, FILM COATED [ARMAS PHARMACEUTICALS INC.] 1 Current NDC, Legacy NDC, 1 package rows 20190315_7b7cc194-29e4-4484-a364-a1ac7d7d6cf5.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72485-203-30 72485020330 30 TABLET, FILM COATED in 1 BOTTLE (72485-203-30) 2019-03-15 0000-00-00 No No Current