Imatinib

Product NDC: 43598-345
11-digit product format: 435980345
Labeler code: 43598
Product ID: 43598-345_d905cdb0-eca9-d4f8-d875-08cb6fd75327
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Imatinib
Dosage form: TABLET
Route: ORAL
Labeler: Dr.Reddy's Laboratories Inc
Application: ANDA206547
Marketing category: ANDA
Marketing start: 2018-08-13
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

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43598-345		D	Discontinued by firm	2026-10-15
excluded package	package	43598-345	43598-345-05	D	Discontinued by firm	2026-10-15
excluded package	package	43598-345	43598-345-30	D	Discontinued by firm	2026-10-15
excluded package	package	43598-345	43598-345-31	D	Discontinued by firm	2026-10-15
excluded package	package	43598-345	43598-345-90	D	Discontinued by firm	2026-10-15

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
A206547-001	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB		2018-08-13
A206547-002	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB		2018-08-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206547-001	AB
A206547-002	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	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206547-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-08-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206547-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2018-08-13	`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	A206547-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206547-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206547-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206547-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206547-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206547-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206547-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206547-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206547-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206547-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206547-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206547-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206547-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206547-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206547-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206547-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206547-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206547-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206547-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206547-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206547-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206547-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206547-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A206547-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206547-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A206547-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206547-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206547-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206547-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206547-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206547-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206547-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206547-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206547-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206547-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A206547-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206547-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A206547-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206547-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206547-002	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

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	SPL version
43598-345-05	Imatinib	500 in 1 CONTAINER	TABLET	500	18
43598-345-30	Imatinib	30 in 1 CONTAINER	TABLET	30	18
43598-345-31	Imatinib	3 in 1 CARTON	TABLET	3	18
43598-345-31	Imatinib	10 in 1 BLISTER PACK	TABLET	10	18
43598-345-90	Imatinib	90 in 1 CONTAINER	TABLET	90	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-345-30	EA - Each	43598-345	2e70cae9-d940-4ff3-a93c-f9cf77e90e9f	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-345	IMATINIB TABLET [DR.REDDY'S LABORATORIES INC]	17	Legacy NDC, 5 package rows	20240615_559dd8e5-11f9-70cd-3fb0-9f9eb8484a37.zip

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	559dd8e5-11f9-70cd-3fb0-9f9eb8484a37	18
403879	imatinib mesylate 400 MG Oral Tablet	PSN	559dd8e5-11f9-70cd-3fb0-9f9eb8484a37	18
403878	imatinib 100 MG Oral Tablet	SCD	559dd8e5-11f9-70cd-3fb0-9f9eb8484a37	18
403879	imatinib 400 MG Oral Tablet	SCD	559dd8e5-11f9-70cd-3fb0-9f9eb8484a37	18
403878	imatinib (as imatinib mesylate) 100 MG Oral Tablet	SY	559dd8e5-11f9-70cd-3fb0-9f9eb8484a37	18
403879	imatinib (as imatinib mesylate) 400 MG Oral Tablet	SY	559dd8e5-11f9-70cd-3fb0-9f9eb8484a37	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-345-05	43598034505	500 TABLET in 1 CONTAINER (43598-345-05)	500 tablet	2018-08-13	0000-00-00	No	No	Current
43598-345-30	43598034530	30 TABLET in 1 CONTAINER (43598-345-30)	30 tablet	2018-08-13	0000-00-00	No	No	Current
43598-345-31	43598034531	3 BLISTER PACK in 1 CARTON (43598-345-31) > 10 TABLET in 1 BLISTER PACK	3 blister pack	2020-09-15	0000-00-00	No	No	Current
43598-345-90	43598034590	90 TABLET in 1 CONTAINER (43598-345-90)	90 tablet	2018-08-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Imatinib	Dr.Reddy's Laboratories Inc \| Hetero Labs Limited \| Dr. Reddy's Laboratories Limited - FTO 7	2025-04-20	HUMAN PRESCRIPTION DRUG LABEL	18