Turalio

Product NDC: 65597-402
11-digit product format: 655970402
Labeler code: 65597
Product ID: 65597-402_591b9371-dac1-46ff-8ecd-070daf2bd8aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pexidartinib
Dosage form: CAPSULE
Route: ORAL
Labeler: Daiichi Sankyo, Inc.
Application: NDA211810
Marketing category: NDA
Marketing start: 2019-08-02
Marketing end: 0000-00-00
Substance: PEXIDARTINIB HYDROCHLORIDE
Active strength: 200 mg/1
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65597-402		D	Discontinued by firm	2026-10-05
excluded package	package	65597-402	65597-402-20	D	Discontinued by firm	2026-10-05
excluded package	package	65597-402	65597-402-28	D	Discontinued by firm	2026-10-05

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65597-402-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65597-402-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65597-402-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65597-402-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65597-402-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65597-402-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65597-402-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65597-402-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65597-402-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65597-402-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65597-402-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65597-402-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65597-402-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65597-402-20	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65597-402-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65597-402-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65597-402-28	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65597-402-20	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65597-402-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65597-402-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65597-402-28	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65597-402-20	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65597-402-28	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65597-402-20	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N211810-001	TURALIO	PEXIDARTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD	2019-08-02
N211810-002	TURALIO	PEXIDARTINIB HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL		RLD, RS	2022-10-14

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211810-001	8404700	2027-11-21		Drug substance	2019-08-28
N211810-001	8722702	2027-11-21		Drug substance	2019-08-28
N211810-001	9169250	2027-11-21		Drug substance	2019-08-28
N211810-001	8461169	2028-04-19	U-2606		2019-08-28
N211810-001	7893075	2033-05-04		Drug substance	2019-08-28
N211810-001	9358235	2033-06-08	U-2606		2019-08-28
N211810-001	10189833	2036-05-05	U-2606		2019-08-28
N211810-001	10730876	2036-05-05		Drug substance	2020-08-31
N211810-001	9802932	2036-05-05		Drug substance	2019-08-28
N211810-001	10435404	2038-07-24		Drug product	2019-10-22
N211810-001	10941142	2038-07-24		Drug product	2021-03-30
N211810-001	10961240	2038-07-24	U-2606		2021-04-21
N211810-002	8404700	2027-11-21		Drug substance	2022-11-14
N211810-002	8722702	2027-11-21		Drug substance	2022-11-14
N211810-002	9169250	2027-11-21		Drug substance	2022-11-14
N211810-002	8461169	2028-04-19	U-2606		2022-11-14
N211810-002	7893075	2033-05-04		Drug substance	2022-11-14
N211810-002	9358235	2033-06-08	U-2606		2022-11-14
N211810-002	10189833	2036-05-05	U-2606		2022-11-14
N211810-002	10730876	2036-05-05		Drug substance	2022-11-14
N211810-002	9802932	2036-05-05		Drug substance	2022-11-14
N211810-002	10435404	2038-07-24		Drug product	2022-11-14
N211810-002	10941142	2038-07-24		Drug product	2022-11-14
N211810-002	10961240	2038-07-24	U-2606		2022-11-14

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211810-001	ODE-250	2026-08-02
N211810-002	ODE*	2026-08-02

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 2 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2022-10-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2022-10-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2022-10-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2022-10-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD	2022-10-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD	2022-10-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD	2022-10-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD	2022-10-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD	2022-10-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD	2022-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD	2022-10-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD	2022-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD	2022-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD	2022-10-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD	2022-10-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD	2019-08-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211810-002	TURALIO	EQ 125MG BASE	CAPSULE / ORAL	RLD	2022-10-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2019-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2019-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2019-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2019-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2019-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2019-08-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2019-08-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211810-001	TURALIO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2019-08-02	`5aa47cf7b7d7…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 799 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211810-001	8404700	2027-11-21		Drug substance	2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-001	8722702	2027-11-21		Drug substance	2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-001	9169250	2027-11-21		Drug substance	2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-001	8461169	2028-04-19	U-2606		2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-001	7893075	2033-05-04		Drug substance	2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-001	9358235	2033-06-08	U-2606		2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-001	10189833	2036-05-05	U-2606		2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-001	10730876	2036-05-05		Drug substance	2020-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-001	9802932	2036-05-05		Drug substance	2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-001	10435404	2038-07-24		Drug product	2019-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-001	10941142	2038-07-24		Drug product	2021-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-001	10961240	2038-07-24	U-2606		2021-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-002	8404700	2027-11-21		Drug substance	2022-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-002	8722702	2027-11-21		Drug substance	2022-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-002	9169250	2027-11-21		Drug substance	2022-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-002	8461169	2028-04-19	U-2606		2022-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-002	7893075	2033-05-04		Drug substance	2022-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-002	9358235	2033-06-08	U-2606		2022-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-002	10189833	2036-05-05	U-2606		2022-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-002	10730876	2036-05-05		Drug substance	2022-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-002	9802932	2036-05-05		Drug substance	2022-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-002	10435404	2038-07-24		Drug product	2022-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-002	10941142	2038-07-24		Drug product	2022-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-002	10961240	2038-07-24	U-2606		2022-11-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211810-001	8404700	2027-11-21		Drug substance	2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-001	8722702	2027-11-21		Drug substance	2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-001	9169250	2027-11-21		Drug substance	2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-001	8461169	2028-04-19	U-2606		2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-001	7893075	2033-05-04		Drug substance	2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-001	9358235	2033-06-08	U-2606		2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-001	10189833	2036-05-05	U-2606		2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-001	10730876	2036-05-05		Drug substance	2020-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-001	9802932	2036-05-05		Drug substance	2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-001	10435404	2038-07-24		Drug product	2019-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-001	10941142	2038-07-24		Drug product	2021-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-001	10961240	2038-07-24	U-2606		2021-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-002	8404700	2027-11-21		Drug substance	2022-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-002	8722702	2027-11-21		Drug substance	2022-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-002	9169250	2027-11-21		Drug substance	2022-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-002	8461169	2028-04-19	U-2606		2022-11-14	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 119 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N211810-001	ODE-250	2026-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211810-002	ODE*	2026-08-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211810-001	ODE-250	2026-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211810-002	ODE*	2026-08-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211810-001	ODE-250	2026-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211810-002	ODE*	2026-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211810-001	ODE-250	2026-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211810-002	ODE*	2026-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211810-001	ODE-250	2026-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211810-002	ODE*	2026-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211810-001	ODE-250	2026-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211810-002	ODE*	2026-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211810-001	ODE-250	2026-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211810-002	ODE*	2026-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211810-001	NCE	2024-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211810-001	ODE-250	2026-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211810-002	NCE	2024-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211810-002	ODE*	2026-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211810-001	NCE	2024-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211810-001	ODE-250	2026-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211810-002	NCE	2024-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211810-002	ODE*	2026-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211810-001	NCE	2024-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211810-001	ODE-250	2026-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211810-002	NCE	2024-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211810-002	ODE*	2026-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211810-001	NCE	2024-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211810-001	ODE-250	2026-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211810-002	NCE	2024-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211810-002	ODE*	2026-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211810-001	NCE	2024-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211810-001	ODE-250	2026-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211810-002	NCE	2024-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211810-002	ODE*	2026-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211810-001	NCE	2024-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211810-001	ODE-250	2026-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211810-002	NCE	2024-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211810-002	ODE*	2026-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211810-001	NCE	2024-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211810-001	ODE-250	2026-08-02	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65597-402-20	EA - Each	65597-402	755e086a-dc1a-435d-8975-2865f8abd2c8	1	2019-09-05
65597-402-28	EA - Each	65597-402	d20b2e3e-d738-4ae2-afa2-85ce84575b0b	1	2019-10-07

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Turalio	PEXIDARTINIB HYDROCHLORIDE	Daiichi Sankyo Inc.	7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16	2025-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211810 application number: NDA211810

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YS6WAI3XN7	PEXIDARTINIB HYDROCHLORIDE	2040295-03-0	PEXIDARTINIB HYDROCHLORIDE
6783M2LV5X	PEXIDARTINIB	1029044-16-3	pexidartinib

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65597-402-20	65597040220	1 BOTTLE in 1 CARTON (65597-402-20) > 120 CAPSULE in 1 BOTTLE	1 bottle	2019-08-02	0000-00-00	No	No	Current
65597-402-28	65597040228	1 BOTTLE in 1 CARTON (65597-402-28) > 28 CAPSULE in 1 BOTTLE	1 bottle	2019-08-02	0000-00-00	No	No	Current