Imatinib Mesylate

Product NDC: 0093-7630
11-digit product format: 000937630
Labeler code: 0093
Product ID: 0093-7630_5c0d390b-c369-4ab3-9cad-38218846adc5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Imatinib Mesylate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA204285
Marketing category: ANDA
Marketing start: 2016-08-04
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: 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
A204285-001	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB		2016-08-04
A204285-002	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB		2016-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204285-001	AB
A204285-002	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	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204285-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204285-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-04	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204285-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204285-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204285-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204285-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204285-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204285-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204285-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204285-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204285-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204285-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204285-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204285-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204285-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204285-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204285-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204285-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204285-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204285-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204285-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204285-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204285-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204285-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204285-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204285-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204285-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204285-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204285-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204285-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204285-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204285-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204285-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204285-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204285-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204285-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204285-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204285-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204285-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204285-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204285-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204285-002	AB	1	`3a93d1ddd44b…`

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	400 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
0093-7630-56	Imatinib Mesylate	30 in 1 BOTTLE	TABLET, FILM COATED	30		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-7630-56	EA - Each	0093-7630	8b24d70d-e4f2-4e3a-8bb9-268ec59c590c	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-7630	IMATINIB MESYLATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	13	Current NDC, Legacy NDC, 1 package rows	20240817_a9cfc301-3c7f-4910-8813-41dcb0b4ca69.zip

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	a9cfc301-3c7f-4910-8813-41dcb0b4ca69	15
403879	imatinib mesylate 400 MG Oral Tablet	PSN	a9cfc301-3c7f-4910-8813-41dcb0b4ca69	15
403878	imatinib 100 MG Oral Tablet	SCD	a9cfc301-3c7f-4910-8813-41dcb0b4ca69	15
403879	imatinib 400 MG Oral Tablet	SCD	a9cfc301-3c7f-4910-8813-41dcb0b4ca69	15
403878	imatinib (as imatinib mesylate) 100 MG Oral Tablet	SY	a9cfc301-3c7f-4910-8813-41dcb0b4ca69	15
403879	imatinib (as imatinib mesylate) 400 MG Oral Tablet	SY	a9cfc301-3c7f-4910-8813-41dcb0b4ca69	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-7630-56	00093763056	30 TABLET, FILM COATED in 1 BOTTLE (0093-7630-56)	2016-08-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Imatinib Mesylate	Teva Pharmaceuticals USA, Inc.	2026-09-15	HUMAN PRESCRIPTION DRUG LABEL	16
Imatinib Mesylate	Golden State Medical Supply, Inc.	2019-12-09	HUMAN PRESCRIPTION DRUG LABEL	5