Home NDC 66828-0030 Gleevec
Product NDC 66828-0030
11-digit product format 668280030
Labeler code 66828
Product ID 66828-0030_d56c24fb-196d-4775-b67f-13c5e41bd150
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name imatinib mesylate
Dosage form TABLET
Route ORAL
Labeler Novartis Pharma Produktions GmbH
Application NDA021588
Marketing category NDA
Marketing start 2001-05-15
Marketing end 0000-00-00
Substance IMATINIB MESYLATE
Active strength 100 mg/1
Pharmacologic classes Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 66828-0030-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 66828-0030-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 66828-0030-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 66828-0030-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 66828-0030-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 66828-0030-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 66828-0030-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 66828-0030-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 66828-0030-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 66828-0030-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 66828-0030-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 66828-0030-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 66828-0030-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 66828-0030-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 66828-0030-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 66828-0030-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 66828-0030-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 66828-0030-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 66828-0030-1 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 66828-0030-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 66828-0030-1 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 66828-0030-1 110d247fa046…a55b01930146…
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 N021588-001 GLEEVEC IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 N021588-002 GLEEVEC IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB RLD 2003-04-18
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 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021588-001 GLEEVEC EQ 100MG BASE TABLET / ORAL AB RLD 2003-04-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021588-002 GLEEVEC EQ 400MG BASE TABLET / ORAL AB RLD, RS 2003-04-18 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 96 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021588-001 6958335*PED 2022-06-19 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021588-002 6958335*PED 2022-06-19 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021588-001 6958335*PED 2022-06-19 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021588-002 6958335*PED 2022-06-19 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021588-001 6958335*PED 2022-06-19 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021588-002 6958335*PED 2022-06-19 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021588-001 RE43932*PED 2019-01-16 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-001 6894051 2019-05-23 U-649 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-001 6894051*PED 2019-11-23 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-001 6958335 2021-12-19 U-1883 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-001 6958335 2021-12-19 U-791 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-001 6958335*PED 2022-06-19 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-002 RE43932*PED 2019-01-16 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-002 6894051 2019-05-23 U-649 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-002 6894051*PED 2019-11-23 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-002 6958335 2021-12-19 U-791 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-002 6958335 2021-12-19 U-1883 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021588-002 6958335*PED 2022-06-19 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021588-001 6958335*PED 2022-06-19 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021588-002 6958335*PED 2022-06-19 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021588-001 6958335 2021-12-19 U-791 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021588-001 6958335 2021-12-19 U-1883 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021588-001 6958335*PED 2022-06-19 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021588-002 6958335 2021-12-19 U-791 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021588-002 6958335 2021-12-19 U-1883 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021588-002 6958335*PED 2022-06-19 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021588-001 6958335 2021-12-19 U-791 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021588-001 6958335 2021-12-19 U-1883 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021588-001 6958335*PED 2022-06-19 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021588-002 6958335 2021-12-19 U-791 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021588-002 6958335 2021-12-19 U-1883 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021588-002 6958335*PED 2022-06-19 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021588-001 6958335 2021-12-19 U-791 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021588-001 6958335 2021-12-19 U-1883 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021588-001 6958335*PED 2022-06-19 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021588-002 6958335 2021-12-19 U-791 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021588-002 6958335 2021-12-19 U-1883 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021588-002 6958335*PED 2022-06-19 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021588-001 6958335 2021-12-19 U-791 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021588-001 6958335 2021-12-19 U-1883 8869cabd3fbd…
Observed Orange Book exclusivity history# FDA-Initiated Inactive NDC Indexing# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gleevec IMATINIB MESYLATE Novartis Pharmaceuticals Corporation 211ef2da-2868-4a77-8055-1cb2cd78e24b 2026-07-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 021588 application number: NDA021588