Home NDC 65162-795 Imatinib Mesylate
Product NDC 65162-795
11-digit product format 651620795
Labeler code 65162
Product ID 65162-795_86a4b0ad-816a-4768-aecd-0fe4a39e51ef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Imatinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA207495
Marketing category ANDA
Marketing start 2019-02-08
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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 A207495-001 IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 A207495-002 IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08
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 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207495-001 IMATINIB MESYLATE EQ 100MG BASE TABLET / ORAL 2019-02-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207495-002 IMATINIB MESYLATE EQ 400MG BASE TABLET / ORAL 2019-02-08 bb7c543d1eb4…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-07-19 19:46 UTC 2019-07 A207495-001 AB 1 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A207495-002 AB 1 ea99ee380514…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-795 IMATINIB MESYLATE (IMATINIB) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] 25 Legacy NDC 20241027_1139f461-dc02-45f0-b8fd-70552315c6d6.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65162-795-03 65162079503 30 TABLET, FILM COATED in 1 BOTTLE (65162-795-03) 2019-02-08 0000-00-00 No No Current 65162-795-09 65162079509 90 TABLET, FILM COATED in 1 BOTTLE (65162-795-09) 2019-02-08 0000-00-00 No No Current