Home NDC 82667-900 VEVYE
Product NDC 82667-900
11-digit product format 826670900
Labeler code 82667
Product ID 82667-900_4bc25aeb-44ca-06b2-e063-6294a90a03c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cyclosporine ophthalmic solution
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Harrow Eye, LLC
Application NDA217469
Marketing category NDA
Marketing start 2023-12-01
Substance CYCLOSPORINE
Active strength 1 mg/mL
Pharmacologic classes Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 N217469-001 VEVYE CYCLOSPORINE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217469-001 8614178 2030-12-13 Drug product 2023-06-22 N217469-001 12496326 2036-09-29 U-3627 2025-12-17 N217469-001 10813976 2037-09-22 Drug product 2023-06-22 N217469-001 11154513 2038-11-20 U-1900 Drug product 2023-06-22 N217469-001 11413323 2039-10-11 U-3627 2023-06-22 N217469-001 12059449 2042-04-01 U-1483 Drug product 2024-09-11
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217469-001 NP 2026-05-30
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 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217469-001 VEVYE 0.1% SOLUTION / OPHTHALMIC RLD, RS 2023-05-30 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 96 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 N217469-001 8614178 2030-12-13 Drug product 2023-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217469-001 12496326 2036-09-29 U-3627 2025-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217469-001 10813976 2037-09-22 Drug product 2023-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217469-001 11154513 2038-11-20 U-1900 Drug product 2023-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217469-001 11413323 2039-10-11 U-3627 2023-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217469-001 12059449 2042-04-01 U-1483 Drug product 2024-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217469-001 8614178 2030-12-13 Drug product 2023-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217469-001 10813976 2037-09-22 Drug product 2023-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217469-001 11154513 2038-11-20 U-1900 Drug product 2023-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217469-001 11413323 2039-10-11 U-3627 2023-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217469-001 12059449 2042-04-01 U-1483 Drug product 2024-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217469-001 8614178 2030-12-13 Drug product 2023-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217469-001 10813976 2037-09-22 Drug product 2023-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217469-001 11154513 2038-11-20 U-1900 Drug product 2023-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217469-001 11413323 2039-10-11 U-3627 2023-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217469-001 12059449 2042-04-01 U-1483 Drug product 2024-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217469-001 8614178 2030-12-13 Drug product 2023-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217469-001 10813976 2037-09-22 Drug product 2023-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217469-001 11154513 2038-11-20 U-1900 Drug product 2023-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217469-001 11413323 2039-10-11 U-3627 2023-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217469-001 12059449 2042-04-01 U-1483 Drug product 2024-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217469-001 8614178 2030-12-13 Drug product 2023-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217469-001 10813976 2037-09-22 Drug product 2023-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217469-001 11154513 2038-11-20 U-1900 Drug product 2023-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217469-001 11413323 2039-10-11 U-3627 2023-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217469-001 12059449 2042-04-01 U-1483 Drug product 2024-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217469-001 8614178 2030-12-13 Drug product 2023-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217469-001 10813976 2037-09-22 Drug product 2023-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217469-001 11154513 2038-11-20 U-1900 Drug product 2023-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217469-001 11413323 2039-10-11 U-3627 2023-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217469-001 12059449 2042-04-01 U-1483 Drug product 2024-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217469-001 8614178 2030-12-13 Drug product 2023-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217469-001 10813976 2037-09-22 Drug product 2023-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217469-001 11154513 2038-11-20 U-1900 Drug product 2023-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217469-001 11413323 2039-10-11 U-3627 2023-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217469-001 12059449 2042-04-01 U-1483 Drug product 2024-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217469-001 8614178 2030-12-13 Drug product 2023-06-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217469-001 10813976 2037-09-22 Drug product 2023-06-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217469-001 11154513 2038-11-20 U-1900 Drug product 2023-06-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217469-001 11413323 2039-10-11 U-3627 2023-06-22 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base VEVYE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOSPORINE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 83HN0GTJ6D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2639936 Internal RxNorm lookup 2639941 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82667-900-00 VEVYE 2 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2 4 82667-900-00 VEVYE 1 in 1 CARTON SOLUTION/ DROPS 1 4 82667-900-02 VEVYE 1 in 1 CARTON SOLUTION/ DROPS 1 4 82667-900-02 VEVYE 2 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82667-900 VEVYE (CYCLOSPORINE OPHTHALMIC SOLUTION) SOLUTION/ DROPS [HARROW EYE, LLC] 1 Current NDC, 4 package rows 20231201_0a60fccf-7e1b-44fe-e063-6394a90aadd5.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VEVYE CYCLOSPORINE OPHTHALMIC SOLUTION Harrow Eye, LLC 0a60fccf-7e1b-44fe-e063-6394a90aadd5 2026-02-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 217469 application number: NDA217469 ndc (product): 82667-900
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82667-900-00 82667090000 1 BOTTLE, DROPPER in 1 CARTON (82667-900-00) / 2 mL in 1 BOTTLE, DROPPER 2026-02-24 Yes No Current 82667-900-02 82667090002 1 BOTTLE, DROPPER in 1 CARTON (82667-900-02) / 2 mL in 1 BOTTLE, DROPPER 2023-12-01 No No Current