Imatinib Mesylate

Product NDC: 60687-882
Requested package NDC: 60687-882-21
11-digit product format: 606870882
Labeler code: 60687
Product ID: 60687-882_5e84bba0-f1ce-884c-e063-6394a90a33d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Imatinib Mesylate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA079179
Marketing category: ANDA
Marketing start: 2025-02-19
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 44.

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
A079179-001	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB		2016-08-05
A079179-002	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB		2016-08-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079179-001	AB
A079179-002	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 · 88 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
2026-10-15 13:18:30	2026-09	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A079179-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079179-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A079179-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079179-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079179-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079179-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079179-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079179-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079179-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079179-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079179-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079179-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079179-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079179-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079179-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079179-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079179-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079179-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079179-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079179-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079179-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079179-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079179-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079179-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079179-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079179-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079179-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079179-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079179-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079179-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079179-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079179-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079179-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079179-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079179-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079179-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079179-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079179-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079179-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079179-002	AB	1	`4b0b4de00fa7…`

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2d2ca280-d5c0-49b4-9bbd-0191c7e031be	Product name	1	20250724
a07e1ba8-e0e6-1fcb-b05d-47e31d308a05	Product name	9	20230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60687-882-11	Imatinib Mesylate	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		2
60687-882-21	Imatinib Mesylate	30 in 1 CARTON	TABLET, FILM COATED	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-882-11	EA - Each	60687-882	c157aed5-80bd-4f5b-9930-e30329fdc56d	1	2025-02-10
60687-882-21	EA - Each	60687-882	99865a12-20de-4ffa-8593-40a1cb5a89b9	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-882	IMATINIB MESYLATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2	Current NDC, 2 package rows	20250223_6e7ed4ef-24e3-4545-9a99-2e34c946e8e7.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imatinib Mesylate	IMATINIB MESYLATE	Apotex Corp	0291eca5-7a1d-4a79-30be-252224d96509	2026-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079179 application number: ANDA079179
Imatinib Mesylate	IMATINIB MESYLATE	Major Pharmaceuticals	7c037022-7fc8-4b6e-9db3-427206c572b4	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079179 application number: ANDA079179
Imatinib Mesylate	IMATINIB MESYLATE	American Health Packaging	6e7ed4ef-24e3-4545-9a99-2e34c946e8e7	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079179 application number: ANDA079179 ndc (package): 60687-882-21 ndc (product): 60687-882 ndc11 (package): 60687088221

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403878	imatinib mesylate 100 MG Oral Tablet	PSN	6e7ed4ef-24e3-4545-9a99-2e34c946e8e7	2
403878	imatinib 100 MG Oral Tablet	SCD	6e7ed4ef-24e3-4545-9a99-2e34c946e8e7	2
403878	imatinib (as imatinib mesylate) 100 MG Oral Tablet	SY	6e7ed4ef-24e3-4545-9a99-2e34c946e8e7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60687-882-21	60687088221	30 BLISTER PACK in 1 CARTON (60687-882-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-882-11)	30 blister pack	2025-02-19	No	No	Current