Home NDC 59651-450 Lifitegrast
Product NDC 59651-450
11-digit product format 596510450
Labeler code 59651
Product ID 59651-450_1d4b4b61-79da-4b6f-bb19-056d111bf400
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lifitegrast
Dosage form FOR SOLUTION
Route OPHTHALMIC
Labeler Aurobindo Pharma Limited
Application ANDA215063
Marketing category ANDA
Marketing start 2023-11-07
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 A215063-001 LIFITEGRAST LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC 2023-11-07
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.
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 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC 2023-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC 2023-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC 2023-11-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC 2023-11-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC 2023-11-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC 2023-11-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC 2023-11-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC 2023-11-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC 2023-11-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC 2023-11-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC 2023-11-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC 2023-11-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC 2023-11-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC AB 2023-11-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC AB 2023-11-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC AB 2023-11-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC AB 2023-11-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC AB 2023-11-07 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215063-001 LIFITEGRAST 5% SOLUTION/DROPS / OPHTHALMIC 2023-11-07 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Lifitegrast
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1801835 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 59651-450-05 Lifitegrast 0.2 mL in 1 AMPULE FOR SOLUTION 0.2 1 59651-450-05 Lifitegrast 5 in 1 POUCH FOR SOLUTION 5 1 59651-450-60 Lifitegrast 60 in 1 CARTON FOR SOLUTION 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-450 LIFITEGRAST FOR SOLUTION [AUROBINDO PHARMA LIMITED] 1 Current NDC, 3 package rows 20231115_1d4b4b61-79da-4b6f-bb19-056d111bf400.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-450-05 59651045005 0.2 mL in 1 AMPULE 0.2 ml Historical 59651-450-60 59651045060 60 POUCH in 1 CARTON (59651-450-60) / 5 AMPULE in 1 POUCH (59651-450-05) / .2 mL in 1 AMPULE 60 pouch 2023-11-07 No No Current