TRUSELTIQ

Product NDC: 72730-202
Requested package NDC: 72730-202-01
11-digit product format: 727300202
Labeler code: 72730
Product ID: 72730-202_0529ba94-9541-4ce3-8b59-0afb1e44e0f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: infigratinib
Dosage form: CAPSULE
Route: ORAL
Labeler: QED Therapeutics, Inc.
Application: NDA214622
Marketing category: NDA
Marketing start: 2021-05-28
Marketing end: 0000-00-00
Substance: INFIGRATINIB
Active strength: 75 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72730-202	72730-202-01	D	Discontinued by firm		2026-08-10

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N214622-001	TRUSELTIQ	INFIGRATINIB PHOSPHATE	25MG	CAPSULE / ORAL		RLD	2021-05-28
N214622-002	TRUSELTIQ	INFIGRATINIB PHOSPHATE	100MG	CAPSULE / ORAL		RLD	2021-05-28

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N214622-001	9067896	2028-08-06	Drug substance	2021-06-08
N214622-001	8552002	2029-08-25	Drug substance, Drug product	2021-06-08
N214622-001	10278969	2034-12-11	Drug product	2021-06-08
N214622-001	11160804	2034-12-11	Drug product	2021-12-01
N214622-002	9067896	2028-08-06	Drug substance	2021-06-08
N214622-002	8552002	2029-08-25	Drug substance, Drug product	2021-06-08
N214622-002	10278969	2034-12-11	Drug product	2021-06-08
N214622-002	11160804	2034-12-11	Drug product	2021-12-01

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214622-001	NCE	2026-05-28
N214622-001	ODE-353	2028-05-28
N214622-002	NCE	2026-05-28
N214622-002	ODE-353	2028-05-28

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 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD	2021-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD	2021-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD	2021-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD	2021-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD	2021-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD	2021-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD	2021-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD	2021-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD	2021-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD	2021-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD	2021-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD	2021-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD	2021-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD	2021-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD, RS	2021-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD, RS	2021-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD, RS	2021-05-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD, RS	2021-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD, RS	2021-05-28	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214622-001	TRUSELTIQ	25MG	CAPSULE / ORAL	RLD	2021-05-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214622-002	TRUSELTIQ	100MG	CAPSULE / ORAL	RLD	2021-05-28	`6a51e52b5d6a…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214622-001	9067896	2028-08-06	Drug substance	2021-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214622-001	8552002	2029-08-25	Drug substance, Drug product	2021-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214622-001	10278969	2034-12-11	Drug product	2021-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214622-001	11160804	2034-12-11	Drug product	2021-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214622-002	9067896	2028-08-06	Drug substance	2021-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214622-002	8552002	2029-08-25	Drug substance, Drug product	2021-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214622-002	10278969	2034-12-11	Drug product	2021-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214622-002	11160804	2034-12-11	Drug product	2021-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214622-001	9067896	2028-08-06	Drug substance	2021-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214622-001	8552002	2029-08-25	Drug substance, Drug product	2021-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214622-001	10278969	2034-12-11	Drug product	2021-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214622-001	11160804	2034-12-11	Drug product	2021-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214622-002	9067896	2028-08-06	Drug substance	2021-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214622-002	8552002	2029-08-25	Drug substance, Drug product	2021-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214622-002	10278969	2034-12-11	Drug product	2021-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214622-002	11160804	2034-12-11	Drug product	2021-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214622-001	9067896	2028-08-06	Drug substance	2021-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214622-001	8552002	2029-08-25	Drug substance, Drug product	2021-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214622-001	10278969	2034-12-11	Drug product	2021-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214622-001	11160804	2034-12-11	Drug product	2021-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214622-002	9067896	2028-08-06	Drug substance	2021-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214622-002	8552002	2029-08-25	Drug substance, Drug product	2021-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214622-002	10278969	2034-12-11	Drug product	2021-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214622-002	11160804	2034-12-11	Drug product	2021-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214622-001	9067896	2028-08-06	Drug substance	2021-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214622-001	8552002	2029-08-25	Drug substance, Drug product	2021-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214622-001	10278969	2034-12-11	Drug product	2021-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214622-001	11160804	2034-12-11	Drug product	2021-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214622-002	9067896	2028-08-06	Drug substance	2021-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214622-002	8552002	2029-08-25	Drug substance, Drug product	2021-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214622-002	10278969	2034-12-11	Drug product	2021-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214622-002	11160804	2034-12-11	Drug product	2021-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214622-001	9067896	2028-08-06	Drug substance	2021-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214622-001	8552002	2029-08-25	Drug substance, Drug product	2021-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214622-001	10278969	2034-12-11	Drug product	2021-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214622-001	11160804	2034-12-11	Drug product	2021-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214622-002	9067896	2028-08-06	Drug substance	2021-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214622-002	8552002	2029-08-25	Drug substance, Drug product	2021-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214622-002	10278969	2034-12-11	Drug product	2021-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214622-002	11160804	2034-12-11	Drug product	2021-12-01	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214622-001	NCE	2026-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214622-001	ODE-353	2028-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214622-002	NCE	2026-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214622-002	ODE-353	2028-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214622-001	NCE	2026-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214622-001	ODE-353	2028-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214622-002	NCE	2026-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214622-002	ODE-353	2028-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214622-001	NCE	2026-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214622-001	ODE-353	2028-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214622-002	NCE	2026-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214622-002	ODE-353	2028-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214622-001	NCE	2026-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214622-001	ODE-353	2028-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214622-002	NCE	2026-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214622-002	ODE-353	2028-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214622-001	NCE	2026-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214622-001	ODE-353	2028-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214622-002	NCE	2026-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214622-002	ODE-353	2028-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214622-001	NCE	2026-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214622-001	ODE-353	2028-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214622-002	NCE	2026-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214622-002	ODE-353	2028-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214622-001	NCE	2026-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214622-001	ODE-353	2028-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214622-002	NCE	2026-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214622-002	ODE-353	2028-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214622-001	NCE	2026-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214622-001	ODE-353	2028-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214622-002	NCE	2026-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214622-002	ODE-353	2028-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214622-001	NCE	2026-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214622-001	ODE-353	2028-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214622-002	NCE	2026-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214622-002	ODE-353	2028-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214622-001	NCE	2026-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214622-001	ODE-353	2028-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214622-002	NCE	2026-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214622-002	ODE-353	2028-05-28	`d06236e962d9…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72730-202-01	2025-07-11	C162847	48780-1	1030e365-2791-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use TRUSELTIQ safely and effectively. See full prescribing information for TRUSELTIQ. TRUSELTIQ (infigratinib) capsules, for oral use Initial U.S. Approval: 2021
72730-202-01	2024-01-30	C162847	48780-1	1030e365-2791-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use TRUSELTIQ safely and effectively. See full prescribing information for TRUSELTIQ. TRUSELTIQ (infigratinib) capsules, for oral use Initial U.S. Approval: 2021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72730-202-01	EA - Each	72730-202	e4dfc727-db75-459a-93bb-a329144db802	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72730-202	TRUSELTIQ (INFIGRATINIB) CAPSULE [QED THERAPEUTICS, INC.]	3	Legacy NDC	20220211_af9a96cf-1cd7-8ace-e053-2a95a90a18cc.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A4055ME1VK	INFIGRATINIB	872511-34-7	INFIGRATINIB

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72730-202-01	72730020201	1 BLISTER PACK in 1 CARTON (72730-202-01) > 63 CAPSULE in 1 BLISTER PACK	1 blister pack	2021-05-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRUSELTIQ	QED Therapeutics, Inc. \| Helsinn Healthcare SA	2022-02-07	HUMAN PRESCRIPTION DRUG LABEL	3