Imatinib mesylate

Product NDC: 72606-557
Requested package NDC: 72606-557-01
11-digit product format: 726060557
Labeler code: 72606
Product ID: 72606-557_49f943af-2ff6-4a87-aabc-1786db9d4ff1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: imatinib mesylate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: CELLTRION USA, INC.
Application: ANDA208302
Marketing category: ANDA
Marketing start: 2019-11-06
Marketing end: 0000-00-00
Substance: IMATINIB MESYLATE
Active strength: 400 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72606-557	72606-557-01	D	Discontinued by firm		2026-08-07

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 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`

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
A208302-001	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB		2019-01-17
A208302-002	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB		2019-01-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A208302-001	AB
A208302-002	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208302-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208302-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208302-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208302-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208302-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208302-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208302-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208302-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208302-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208302-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208302-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208302-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208302-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208302-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208302-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208302-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208302-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208302-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208302-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208302-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208302-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208302-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208302-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208302-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208302-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208302-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208302-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208302-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208302-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208302-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208302-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208302-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208302-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208302-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208302-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208302-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208302-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208302-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208302-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208302-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72606-557-01	EA - Each	72606-557	7d06c05b-0eee-4ced-aeeb-72ba5fed3a6d	1	2019-12-10

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imatinib mesylate 400 mg	IMATINIB MESYLATE	Armas Pharmaceuticals Inc.	7b7cc194-29e4-4484-a364-a1ac7d7d6cf5	2019-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208302 application number: ANDA208302
Imatinib mesylate	IMATINIB MESYLATE	Armas Pharmaceuticals Inc.	2e931c49-6c9f-41e2-a34b-5f01cd295b56	2019-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208302 application number: ANDA208302
Imatinib mesylate	IMATINIB MESYLATE	Ascend Laboratories, LLC	7579620e-3748-46fa-8295-f9b47d0aa5b8	2019-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208302 application number: ANDA208302

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8A1O1M485B	IMATINIB MESYLATE	220127-57-1	IMATINIB MESYLATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72606-557-01	72606055701	30 TABLET, FILM COATED in 1 BOTTLE (72606-557-01)	2019-11-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Imatinib mesylate	CELLTRION USA, INC. \| Shilpa Medicare Ltd.	2019-11-07	Human Prescription Drug Label	2