Xiidra

Product NDC: 54092-606
11-digit product format: 540920606
Labeler code: 54092
Product ID: 54092-606_2648ebbb-5b5e-4497-adc2-db90088ba884
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lifitegrast
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA208073
Marketing category: NDA
Marketing start: 2016-07-11
Marketing end: 2023-03-31
Substance: LIFITEGRAST
Active strength: 50 mg/mL
Pharmacologic classes: Lymphocyte Function-Associated Antigen-1 Antagonist [EPC],Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54092-606		D	Discontinued by firm	2026-08-03
excluded package	package	54092-606	54092-606-01	D	Discontinued by firm	2026-08-03
excluded package	package	54092-606	54092-606-02	D	Discontinued by firm	2026-08-03
excluded package	package	54092-606	54092-606-04	D	Discontinued by firm	2026-08-03

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 · 48 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	54092-606-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54092-606-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54092-606-02	`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	54092-606-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54092-606-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54092-606-02	`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	54092-606-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54092-606-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54092-606-02	`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	54092-606-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54092-606-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54092-606-02	`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	54092-606-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54092-606-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54092-606-02	`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	54092-606-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54092-606-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54092-606-02	`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	54092-606-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54092-606-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54092-606-02	`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	54092-606-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54092-606-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54092-606-02	`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	54092-606-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54092-606-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54092-606-02	`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	54092-606-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54092-606-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54092-606-02	`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	54092-606-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54092-606-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54092-606-02	`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	54092-606-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54092-606-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54092-606-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208073-001	XIIDRA	LIFITEGRAST	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11

Orange Book patents#

Current patent rows page 1 of 1 · 11 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208073-001	8084047	2026-05-17		Drug substance, Drug product	2016-08-03
N208073-001	8592450	2026-05-17	U-1880		2016-08-03
N208073-001	8367701	2029-04-15	U-1880	Drug product	2016-08-03
N208073-001	9447077	2029-04-15	U-1900		2016-10-06
N208073-001	8168655	2029-05-09	U-1880		2016-08-03
N208073-001	7314938	2029-06-25		Drug substance, Drug product	2016-08-03
N208073-001	9353088	2030-10-21		Drug product	2016-08-03
N208073-001	9890141	2030-10-21		Drug substance	2018-03-05
N208073-001	8927574	2030-11-12		Drug product	2016-08-03
N208073-001	9085553	2033-07-25		Drug product	2016-08-03
N208073-001	11058677	2033-12-18		Drug product	2021-07-23

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-07-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-07-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-07-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-07-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-07-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-07-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208073-001	XIIDRA	5%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-07-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208073-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208073-001	AB	1	`d06236e962d9…`
2024-05-31 18:47 UTC	2024-05	N208073-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208073-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208073-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208073-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208073-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208073-001	AB	1	`9b2671bbb829…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 617 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208073-001	8084047	2026-05-17		Drug substance, Drug product	2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208073-001	8592450	2026-05-17	U-1880		2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208073-001	8367701	2029-04-15	U-1880	Drug product	2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208073-001	9447077	2029-04-15	U-1900		2016-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208073-001	8168655	2029-05-09	U-1880		2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208073-001	9353088	2030-10-21		Drug product	2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208073-001	9890141	2030-10-21		Drug substance	2018-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208073-001	8927574	2030-11-12		Drug product	2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208073-001	9085553	2033-07-25		Drug product	2016-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208073-001	11058677	2033-12-18		Drug product	2021-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208073-001	7314938	2025-03-10		Drug substance, Drug product	2016-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208073-001	8084047	2026-05-17		Drug substance, Drug product	2016-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208073-001	8592450	2026-05-17	U-1880		2016-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208073-001	8367701	2029-04-15	U-1880	Drug product	2016-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208073-001	9447077	2029-04-15	U-1900		2016-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208073-001	8168655	2029-05-09	U-1880		2016-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208073-001	9353088	2030-10-21		Drug product	2016-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208073-001	9890141	2030-10-21		Drug substance	2018-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208073-001	8927574	2030-11-12		Drug product	2016-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208073-001	9085553	2033-07-25		Drug product	2016-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208073-001	11058677	2033-12-18		Drug product	2021-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208073-001	7314938	2025-03-10		Drug substance, Drug product	2016-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208073-001	8084047	2026-05-17		Drug substance, Drug product	2016-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208073-001	8592450	2026-05-17	U-1880		2016-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208073-001	8367701	2029-04-15	U-1880	Drug product	2016-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208073-001	9447077	2029-04-15	U-1900		2016-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208073-001	8168655	2029-05-09	U-1880		2016-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208073-001	9353088	2030-10-21		Drug product	2016-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208073-001	9890141	2030-10-21		Drug substance	2018-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208073-001	8927574	2030-11-12		Drug product	2016-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208073-001	9085553	2033-07-25		Drug product	2016-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208073-001	11058677	2033-12-18		Drug product	2021-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208073-001	7314938	2025-03-10		Drug substance, Drug product	2016-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208073-001	8084047	2026-05-17		Drug substance, Drug product	2016-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208073-001	8592450	2026-05-17	U-1880		2016-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208073-001	8367701	2029-04-15	U-1880	Drug product	2016-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208073-001	9447077	2029-04-15	U-1900		2016-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208073-001	8168655	2029-05-09	U-1880		2016-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208073-001	9353088	2030-10-21		Drug product	2016-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208073-001	9890141	2030-10-21		Drug substance	2018-03-05	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208073-001	NCE	2021-07-11	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N208073-001	NCE	2021-07-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208073-001	NCE	2021-07-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208073-001	NCE	2021-07-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208073-001	NCE	2021-07-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208073-001	NCE	2021-07-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208073-001	NCE	2021-07-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208073-001	NCE	2021-07-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208073-001	NCE	2021-07-11	`ea99ee380514…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xiidra	LIFITEGRAST	Novartis Pharmaceuticals Corporation	8589d376-ac10-4ddb-9c53-2e0c8d5675c4	2025-08-18	Adverse reactions	Exact identifier application applno (NDA): 208073 application number: NDA208073
Xiidra	LIFITEGRAST	Bausch & Lomb Incorporated	1a914080-a3c0-44be-b601-0ae3160e77eb	2024-11-21	Adverse reactions	Exact identifier application applno (NDA): 208073 application number: NDA208073

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
038E5L962W	LIFITEGRAST	1025967-78-5	LIFITEGRAST

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54092-606-01	54092060601	12 POUCH in 1 CARTON (54092-606-01) > 5 AMPULE in 1 POUCH (54092-606-06) > .2 mL in 1 AMPULE	12 pouch	2016-07-11	2023-02-28	No	No	Current
54092-606-02	54092060602	12 POUCH in 1 CARTON (54092-606-02) > 5 AMPULE in 1 POUCH (54092-606-07) > .2 mL in 1 AMPULE	12 pouch	2016-07-11	2023-03-31	No	No	Current
54092-606-04	54092060604	4 POUCH in 1 CARTON (54092-606-04) > 5 AMPULE in 1 POUCH (54092-606-07) > .2 mL in 1 AMPULE	4 pouch	2016-07-11	2023-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Xiidra	Takeda Pharmaceuticals America, Inc. \| The Ritedose Corporation \| Cambrex Charles City, Inc \| AMRI Rensselaer, Inc. \| SGS Life Science Services \| Albany Molecular Research, Inc. \| ACM PHARMA \| PPD Development, L.P. \| Sharp Corporation \| Laboratoire Unither	2021-10-05	HUMAN PRESCRIPTION DRUG LABEL	9