Xiidra

Product NDC: 24208-911
11-digit product format: 242080911
Labeler code: 24208
Product ID: 24208-911_2770cd53-f66c-2097-e063-6394a90a874b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lifitegrast
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Bausch & Lomb Incorporated
Application: NDA208073
Marketing category: NDA
Marketing start: 2024-01-02
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Xiidra
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIFITEGRAST	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
038E5L962W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1801835	Internal RxNorm lookup
1801840	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1a914080-a3c0-44be-b601-0ae3160e77eb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
4073022c-5d5d-48f5-82ed-091ad146a4b2	Product name	1	20171211
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
ef78cb32-15f8-4d2d-9107-ca3997b019cf	Product name	1	20160819
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
24208-911-05	Xiidra	0.2 mL in 1 AMPULE	SOLUTION/ DROPS	0.2	5
24208-911-05	Xiidra	5 in 1 POUCH	SOLUTION/ DROPS	5	5
24208-911-12	Xiidra	12 in 1 CARTON	SOLUTION/ DROPS	12	5
24208-911-94	Xiidra	4 in 1 CARTON	SOLUTION/ DROPS	4	5
24208-911-95	Xiidra	5 in 1 POUCH	SOLUTION/ DROPS	5	5
24208-911-95	Xiidra	0.2 mL in 1 AMPULE	SOLUTION/ DROPS	0.2	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-911-05	EA - Each	24208-911	4d791291-2155-4d98-b23e-ad28c5d12555	1	2024-12-10
24208-911-12	EA - Each	24208-911	4ef786d7-7691-454c-af08-d4ddc6de070d	1	2024-12-10
24208-911-94	EA - Each	24208-911	cf89329f-9421-4a1e-9bd5-0f0007a92d5e	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24208-911	XIIDRA (LIFITEGRAST) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5	Current NDC, 6 package rows	20241123_1a914080-a3c0-44be-b601-0ae3160e77eb.zip

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 ndc (product): 24208-911

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1801835	lifitegrast 5 % Ophthalmic Solution	PSN	1a914080-a3c0-44be-b601-0ae3160e77eb	5
1801840	xiidra 5 % Ophthalmic Solution	PSN	1a914080-a3c0-44be-b601-0ae3160e77eb	5
1801840	lifitegrast 50 MG/ML Ophthalmic Solution [Xiidra]	SBD	1a914080-a3c0-44be-b601-0ae3160e77eb	5
1801835	lifitegrast 50 MG/ML Ophthalmic Solution	SCD	1a914080-a3c0-44be-b601-0ae3160e77eb	5
1801835	lifitegrast 5 % Ophthalmic Solution	SY	1a914080-a3c0-44be-b601-0ae3160e77eb	5
1801840	xiidra 50 MG/ML Ophthalmic Solution	SY	1a914080-a3c0-44be-b601-0ae3160e77eb	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
24208-911-05	24208091105	0.2 mL in 1 AMPULE	0.2 ml				Historical
24208-911-12	24208091112	12 POUCH in 1 CARTON (24208-911-12) / 5 AMPULE in 1 POUCH (24208-911-05) / .2 mL in 1 AMPULE	12 pouch	2024-01-02	No	No	Current
24208-911-94	24208091194	4 POUCH in 1 CARTON (24208-911-94) / 5 AMPULE in 1 POUCH (24208-911-95) / .2 mL in 1 AMPULE	4 pouch	2024-01-02	Yes	No	Current
24208-911-95	24208091195	5 in 1 POUCH					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Xiidra	Bausch & Lomb Incorporated \| The Ritedose Corporation	2024-11-21	HUMAN PRESCRIPTION DRUG LABEL	5