Home NDC 0078-0401 Gleevec
Product NDC 0078-0401
11-digit product format 000780401
Labeler code 0078
Product ID 0078-0401_cbc7561e-5e16-4e05-9c07-52626c43eafc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name imatinib mesylate
Dosage form TABLET
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA021588
Marketing category NDA
Marketing start 2001-05-15
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 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 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# Additional Listing Data#
Finished product Yes
Brand name base Gleevec
Listing expiration 2027-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403878 Internal RxNorm lookup 403879 Internal RxNorm lookup 404588 Internal RxNorm lookup 404589 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 0078-0401-34 Gleevec 90 in 1 BOTTLE TABLET 90 40
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0401 GLEEVEC (IMATINIB MESYLATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 35 Current NDC, Legacy NDC, 1 package rows 20240724_211ef2da-2868-4a77-8055-1cb2cd78e24b.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.
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 ndc (product): 0078-0401
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 0078-0401-34 00078040134 90 TABLET in 1 BOTTLE (0078-0401-34) 90 tablet 2001-05-15 0000-00-00 No No Current