Home NDC 0078-0911 Xiidra
Product NDC 0078-0911
11-digit product format 000780911
Labeler code 0078
Product ID 0078-0911_3cabbaea-c2bf-971c-e063-6394a90a4931
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lifitegrast
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Novartis Pharmaceuticals Corporation
Application NDA208073
Marketing category NDA
Marketing start 2016-07-11
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# 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# 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-0911-05 Xiidra 0.2 mL in 1 AMPULE SOLUTION/ DROPS 0.2 6 0078-0911-05 Xiidra 5 in 1 POUCH SOLUTION/ DROPS 5 6 0078-0911-12 Xiidra 12 in 1 CARTON SOLUTION/ DROPS 12 6 0078-0911-94 Xiidra 4 in 1 CARTON SOLUTION/ DROPS 4 6 0078-0911-95 Xiidra 5 in 1 POUCH SOLUTION/ DROPS 5 6 0078-0911-95 Xiidra 0.2 mL in 1 AMPULE SOLUTION/ DROPS 0.2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0911 XIIDRA (LIFITEGRAST) SOLUTION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION] 5 Current NDC, Legacy NDC, 6 package rows 20230803_8589d376-ac10-4ddb-9c53-2e0c8d5675c4.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0911-05 00078091105 0.2 mL in 1 AMPULE 0.2 ml Historical 0078-0911-12 00078091112 12 POUCH in 1 CARTON (0078-0911-12) / 5 AMPULE in 1 POUCH (0078-0911-05) / .2 mL in 1 AMPULE 12 pouch 2020-06-04 2027-06-01 No No Current 0078-0911-94 00078091194 4 POUCH in 1 CARTON (0078-0911-94) / 5 AMPULE in 1 POUCH (0078-0911-95) / .2 mL in 1 AMPULE 4 pouch 2020-06-04 2027-02-01 Yes No Current 0078-0911-95 00078091195 5 in 1 POUCH Historical