Imatinib Mesylate

Product NDC: 48433-049
Requested package NDC: 48433-049-03
11-digit product format: 484330049
Labeler code: 48433
Product ID: 48433-049_4fa8a009-9b1c-3138-e063-6294a90a7320
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: imatinib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Safecor Health, LLC
Application: ANDA204644
Marketing category: ANDA
Marketing start: 2026-04-10
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 43.

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
A204644-001	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB		2017-06-21
A204644-002	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB		2017-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204644-001	AB
A204644-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204644-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204644-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204644-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204644-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204644-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204644-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204644-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204644-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204644-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204644-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204644-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204644-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204644-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204644-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204644-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204644-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204644-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204644-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204644-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204644-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204644-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204644-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204644-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204644-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204644-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204644-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204644-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204644-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204644-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204644-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204644-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204644-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204644-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204644-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204644-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204644-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204644-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204644-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204644-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204644-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Imatinib Mesylate
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 · 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f4acacbd-13f8-4a46-b615-b639a17f331f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2d2ca280-d5c0-49b4-9bbd-0191c7e031be	Product name	1	20250724
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
a07e1ba8-e0e6-1fcb-b05d-47e31d308a05	Product name	9	20230314
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48433-049-01	Imatinib Mesylate	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		2
48433-049-03	Imatinib Mesylate	30 in 1 CARTON	TABLET, FILM COATED	30		2

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imatinib Mesylate	IMATINIB	Mylan Pharmaceuticals Inc.	a1787fad-3612-43e1-98fa-ce62361e0b3c	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204644 application number: ANDA204644
Imatinib Mesylate	IMATINIB	Golden State Medical Supply, Inc.	9131b2ce-752d-3a30-e053-2a95a90adaab	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204644 application number: ANDA204644
Imatinib Mesylate	IMATINIB	Safecor Health, LLC	f4acacbd-13f8-4a46-b615-b639a17f331f	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204644 application number: ANDA204644 ndc (package): 48433-049-03 ndc (product): 48433-049 ndc11 (package): 48433004903
Imatinib Mesylate	IMATINIB	Mylan Institutional Inc	1debf3a0-7587-47d7-8ea6-e739698d7297	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204644 application number: ANDA204644

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8A1O1M485B	IMATINIB MESYLATE	220127-57-1	IMATINIB MESYLATE
BKJ8M8G5HI	IMATINIB	152459-95-5	imatinib

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403878	imatinib mesylate 100 MG Oral Tablet	PSN	f4acacbd-13f8-4a46-b615-b639a17f331f	2
403879	imatinib mesylate 400 MG Oral Tablet	PSN	f4acacbd-13f8-4a46-b615-b639a17f331f	2
403878	imatinib 100 MG Oral Tablet	SCD	f4acacbd-13f8-4a46-b615-b639a17f331f	2
403879	imatinib 400 MG Oral Tablet	SCD	f4acacbd-13f8-4a46-b615-b639a17f331f	2
403878	imatinib (as imatinib mesylate) 100 MG Oral Tablet	SY	f4acacbd-13f8-4a46-b615-b639a17f331f	2
403879	imatinib (as imatinib mesylate) 400 MG Oral Tablet	SY	f4acacbd-13f8-4a46-b615-b639a17f331f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
48433-049-03	48433004903	30 BLISTER PACK in 1 CARTON (48433-049-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-049-01)	30 blister pack	2026-04-10	No	No	Current