Home NDC 67184-0533-1 imatinib mesylate
Product NDC 67184-0533
Requested package NDC 67184-0533-1
11-digit product format 671840533
Labeler code 67184
Product ID 67184-0533_a41dbedd-ee4e-401c-b446-a435929ff903
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name imatinib mesylate
Dosage form TABLET
Route ORAL
Labeler Qilu Pharmaceutical Co., Ltd.
Application ANDA212135
Marketing category ANDA
Marketing start 2022-06-21
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 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 A212135-001 IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 A212135-002 IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21
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.
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 2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 e64feba35796…2022-09-29 23:25 UTC 2022-09 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 cb3db0bc1861…2026-08-01 22:54:32 2026-06 A212135-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL AB 2022-06-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A212135-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL AB 2022-06-21 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
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 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 67184-0533-1 imatinib mesylate 30 in 1 BOTTLE TABLET 30 35 67184-0533-2 imatinib mesylate 300 in 1 BOTTLE TABLET 300 35 67184-0533-3 imatinib mesylate 10 in 1 BLISTER PACK TABLET 10 35 67184-0533-3 imatinib mesylate 30 in 1 CARTON TABLET 30 35
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67184-0533 IMATINIB MESYLATE TABLET [QILU PHARMACEUTICAL CO., LTD.] 35 Current NDC, Legacy NDC, 4 package rows 20241207_82eb01e0-8685-4f06-8a72-7663e8ded38f.zip
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 67184-0533-1 67184053301 30 TABLET in 1 BOTTLE (67184-0533-1) 30 tablet 2022-06-21 0000-00-00 No No Current