Home NDC 65086-001-05 Verkazia
Product NDC 65086-001
Requested package NDC 65086-001-05
11-digit product format 650860001
Labeler code 65086
Product ID 65086-001_2becea0d-7cbe-6b23-e063-6294a90a5a67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cyclosporine
Dosage form EMULSION
Route OPHTHALMIC; TOPICAL
Labeler Santen Incorporated
Application NDA214965
Marketing category NDA
Marketing start 2022-02-01
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 2026-12-31
Current FDA listing Yes 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 65086-001 65086-001-05 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 N214965-001 VERKAZIA CYCLOSPORINE 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214965-001 11612658 2026-01-27 U-3560 2023-04-25 N214965-001 7973081 2026-01-27 Drug product 2021-07-15 N214965-001 8524779 2026-01-27 Drug product 2021-07-15 N214965-001 9220694 2026-01-27 Drug product 2021-07-15 N214965-001 9956289 2026-01-27 Drug product 2021-07-15 N214965-001 8298568 2027-11-03 Drug product 2021-07-15 N214965-001 9132071 2029-06-02 Drug product 2021-07-15
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214965-001 ODE-358 2028-06-23
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.
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 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214965-001 VERKAZIA 0.1% EMULSION / OPHTHALMIC RLD, RS 2021-06-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 6 · 220 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 N214965-001 11612658 2026-01-27 U-3560 2023-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214965-001 7973081 2026-01-27 Drug product 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214965-001 8524779 2026-01-27 Drug product 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214965-001 9220694 2026-01-27 Drug product 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214965-001 9956289 2026-01-27 Drug product 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214965-001 8298568 2027-11-03 Drug product 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214965-001 9132071 2029-06-02 Drug product 2021-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 11612658 2026-01-27 U-3560 2023-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 7973081 2026-01-27 Drug product 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 8524779 2026-01-27 Drug product 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 9220694 2026-01-27 Drug product 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 9956289 2026-01-27 Drug product 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 8298568 2027-11-03 Drug product 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214965-001 9132071 2029-06-02 Drug product 2021-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214965-001 11612658 2026-01-27 U-3560 2023-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214965-001 7973081 2026-01-27 Drug product 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214965-001 8524779 2026-01-27 Drug product 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214965-001 9220694 2026-01-27 Drug product 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214965-001 9956289 2026-01-27 Drug product 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214965-001 8298568 2027-11-03 Drug product 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214965-001 9132071 2029-06-02 Drug product 2021-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 11612658 2026-01-27 U-3560 2023-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 7973081 2026-01-27 Drug product 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 8524779 2026-01-27 Drug product 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 9220694 2026-01-27 Drug product 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 9956289 2026-01-27 Drug product 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 8298568 2027-11-03 Drug product 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214965-001 9132071 2029-06-02 Drug product 2021-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 11612658 2026-01-27 U-3560 2023-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 7973081 2026-01-27 Drug product 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 8524779 2026-01-27 Drug product 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 9220694 2026-01-27 Drug product 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 9956289 2026-01-27 Drug product 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 8298568 2027-11-03 Drug product 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214965-001 9132071 2029-06-02 Drug product 2021-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214965-001 11612658 2026-01-27 U-3560 2023-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214965-001 7973081 2026-01-27 Drug product 2021-07-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214965-001 8524779 2026-01-27 Drug product 2021-07-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214965-001 9220694 2026-01-27 Drug product 2021-07-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214965-001 9956289 2026-01-27 Drug product 2021-07-15 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 60 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Verkazia
Listing expiration 2026-12-31 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 2590608 Internal RxNorm lookup 2590613 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 65086-001-05 Verkazia 1 in 1 CARTON EMULSION 1 6 65086-001-05 Verkazia 5 in 1 POUCH EMULSION 5 6 65086-001-12 Verkazia 24 in 1 CARTON EMULSION 24 6 65086-001-12 Verkazia 5 in 1 POUCH EMULSION 5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65086-001 VERKAZIA (CYCLOSPORINE) EMULSION [SANTEN INCORPORATED] 6 Current NDC, Legacy NDC, 4 package rows 20250119_c795cd2f-89da-78e3-e053-2a95a90a9422.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 65086-001-05 65086000105 1 POUCH in 1 CARTON (65086-001-05) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE 1 pouch 2022-02-01 0000-00-00 Yes No Current