Home NDC 54092-606-04 Xiidra
Product NDC 54092-606
Requested package NDC 54092-606-04
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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# 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# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54092-606-04 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