Home NDC 82009-086 Imatinib Mesylate
Product NDC 82009-086
11-digit product format 820090086
Labeler code 82009
Product ID 82009-086_92ab5711-1241-43d8-9e2c-47c973ca0cc1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Imatinib Mesylate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler QUALLENT PHARMACEUTICALS HEALTH LLC
Application ANDA212773
Marketing category ANDA
Marketing start 2023-09-01
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 A212773-001 IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 A212773-002 IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23
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 2 · 74 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 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212773-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2020-07-23 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212773-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2020-07-23 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Imatinib Mesylate
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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82009-086-90 Imatinib Mesylate 90 in 1 BOTTLE TABLET, FILM COATED 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82009-086 IMATINIB MESYLATE TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC] 2 Current NDC, 1 package rows 20230917_a819a954-41c9-4d49-a74e-c8c4b338b22a.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 Sample Exclude flag Status 82009-086-90 82009008690 90 TABLET, FILM COATED in 1 BOTTLE (82009-086-90) 2023-09-01 No No Current