Home NDC 60505-6202 Cyclosporine
Product NDC 60505-6202
11-digit product format 605056202
Labeler code 60505
Product ID 60505-6202_58c5fb86-01c3-497b-86f7-a65055732970
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclosporine
Dosage form EMULSION
Route OPHTHALMIC
Labeler Apotex Corp
Application NDA050790
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-02-07
Substance CYCLOSPORINE
Active strength .5 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050790-001 RESTASIS CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 N050790-002 RESTASIS MULTIDOSE CYCLOSPORINE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050790-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N050790-002 8292129 2031-02-25 Drug product, Delist requested 2017-06-26 N050790-002 8561859 2032-04-16 Drug product, Delist requested 2017-06-26 N050790-002 9676525 2034-02-07 Drug product, Delist requested 2017-06-26 N050790-002 9669974 2034-05-11 Drug product, Delist requested 2017-06-26
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 3 · 82 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 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC RLD, RS 2002-12-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC AB RLD, RS 2002-12-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050790-001 RESTASIS 0.05% EMULSION / OPHTHALMIC RLD, RS 2002-12-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050790-002 RESTASIS MULTIDOSE 0.05% EMULSION / OPHTHALMIC RLD, RS 2016-10-27 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 11 · 428 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 N050790-002 8292129 2031-02-25 Drug product, Delist requested 2017-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050790-002 8561859 2032-04-16 Drug product, Delist requested 2017-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050790-002 9676525 2034-02-07 Drug product, Delist requested 2017-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050790-002 9669974 2034-05-11 Drug product, Delist requested 2017-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050790-002 8292129 2031-02-25 Drug product, Delist requested 2017-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050790-002 8561859 2032-04-16 Drug product, Delist requested 2017-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050790-002 9676525 2034-02-07 Drug product, Delist requested 2017-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050790-002 9669974 2034-05-11 Drug product, Delist requested 2017-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050790-002 8292129 2031-02-25 Drug product, Delist requested 2017-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050790-002 8561859 2032-04-16 Drug product, Delist requested 2017-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050790-002 9676525 2034-02-07 Drug product, Delist requested 2017-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050790-002 9669974 2034-05-11 Drug product, Delist requested 2017-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050790-002 8292129 2031-02-25 Drug product 2017-06-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050790-002 8561859 2032-04-16 Drug product 2017-06-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050790-002 9676525 2034-02-07 Drug product 2017-06-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050790-002 9669974 2034-05-11 Drug product 2017-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050790-002 8292129 2031-02-25 Drug product 2017-06-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050790-002 8561859 2032-04-16 Drug product 2017-06-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050790-002 9676525 2034-02-07 Drug product 2017-06-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050790-002 9669974 2034-05-11 Drug product 2017-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050790-002 8629111 2024-08-27 Drug product, Delist requested 2016-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050790-002 8633162 2024-08-27 U-1479 Delist requested 2016-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050790-002 8642556 2024-08-27 Drug product, Delist requested 2016-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050790-002 8648048 2024-08-27 U-1483 Delist requested 2016-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050790-002 8685930 2024-08-27 Drug product, Delist requested 2016-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050790-002 9248191 2024-08-27 U-1479 Delist requested 2016-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050790-002 8292129 2031-02-25 Drug product 2017-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050790-002 8561859 2032-04-16 Drug product 2017-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050790-002 9676525 2034-02-07 Drug product 2017-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050790-002 9669974 2034-05-11 Drug product 2017-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050790-002 8629111 2024-08-27 Drug product, Delist requested 2016-11-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050790-002 8633162 2024-08-27 U-1479 Delist requested 2016-11-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050790-002 8642556 2024-08-27 Drug product, Delist requested 2016-11-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050790-002 8648048 2024-08-27 U-1483 Delist requested 2016-11-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050790-002 8685930 2024-08-27 Drug product, Delist requested 2016-11-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050790-002 9248191 2024-08-27 U-1479 Delist requested 2016-11-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050790-002 8292129 2031-02-25 Drug product 2017-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050790-002 8561859 2032-04-16 Drug product 2017-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050790-002 9676525 2034-02-07 Drug product 2017-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050790-002 9669974 2034-05-11 Drug product 2017-06-26 2680178bc6a6…
Additional Listing Data#
Finished product Yes
Brand name base Cyclosporine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOSPORINE .5 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2572292 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 60505-6202-1 Cyclosporine 30 in 1 TRAY EMULSION 30 4 60505-6202-1 Cyclosporine 0.4 mL in 1 VIAL EMULSION 0.4 4 60505-6202-2 Cyclosporine 60 in 1 TRAY EMULSION 60 4 60505-6202-2 Cyclosporine 0.4 mL in 1 VIAL EMULSION 0.4 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-6202 CYCLOSPORINE EMULSION [APOTEX CORP] 4 Current NDC, Legacy NDC, 4 package rows 20241228_70c8a4a6-ebe2-457f-a626-400c338cec2d.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 · 6 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Restasis MultiDose CYCLOSPORINE Allergan, Inc. 7224d810-bb96-4682-a942-3355e6e8061a 2025-08-21 Warnings, Adverse reactions Exact identifier application applno (NDA): 050790 application number: NDA050790 Cyclosporine CYCLOSPORINE Apotex Corp 70c8a4a6-ebe2-457f-a626-400c338cec2d 2024-09-23 Warnings, Adverse reactions Exact identifier application applno (NDA): 050790 application number: NDA050790 ndc (product): 60505-6202 Cyclosporine CYCLOSPORINE KVK-TECH, INC. a7040dc6-063b-40ee-8f2a-153e87b08430 2024-09-23 Warnings, Adverse reactions Exact identifier application applno (NDA): 050790 application number: NDA050790 RESTASIS CYCLOSPORINE Allergan, Inc. 8e24af2b-bc1c-4849-94f2-6df950cdca89 2024-09-09 Warnings, Adverse reactions Exact identifier application applno (NDA): 050790 application number: NDA050790 CYCLOSPORINE CYCLOSPORINE Lupin Pharmaceuticals, Inc. 9aca2026-af86-4e97-925e-c202b87c46ac 2024-09-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 050790 application number: NDA050790 RESTASIS CYCLOSPORINE A-S Medication Solutions ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03 2024-05-24 Warnings, Adverse reactions Exact identifier application applno (NDA): 050790 application number: NDA050790
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 60505-6202-1 60505620201 30 VIAL in 1 TRAY (60505-6202-1) / .4 mL in 1 VIAL 30 vial 2022-02-07 0000-00-00 No No Current 60505-6202-2 60505620202 60 VIAL in 1 TRAY (60505-6202-2) / .4 mL in 1 VIAL 60 vial 2022-02-07 0000-00-00 No No Current