RESTASIS

Product NDC: 50090-4476
Requested package NDC: 50090-4476-0
11-digit product format: 500904476
Labeler code: 50090
Product ID: 50090-4476_0a22357f-0136-44d5-ab37-0a7d15287b30
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cyclosporine
Dosage form: EMULSION
Route: OPHTHALMIC
Labeler: A-S Medication Solutions
Application: NDA050790
Marketing category: NDA
Marketing start: 2003-04-01
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

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 · 3 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	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-4476	50090-4476-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-4476	50090-4476-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-4476	50090-4476-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050790-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050790-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050790-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050790-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050790-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050790-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050790-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050790-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050790-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050790-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050790-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050790-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050790-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050790-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050790-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050790-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050790-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N050790-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050790-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050790-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050790-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050790-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050790-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050790-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050790-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050790-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050790-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050790-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050790-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050790-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050790-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050790-001	AB	1	`a50c72e98297…`

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: RESTASIS
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2572292	Internal RxNorm lookup
2572293	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1be408a0-e15a-4092-b35e-4e294e65196f	Product name	3	20240216
b3fdee3e-0c46-442f-aad5-aa71941d5621	Product name	1	20231023
78fb0708-fce5-decd-6611-5a9fbe3e3dec	Product name	3	20230327
54840517-000d-4fcb-b976-a6ddd102faa0	Product name	1	20220120
a5ba3bd0-8411-4005-ac3b-a41d8ee0633a	Product name	1	20181029
b1c0d609-8b97-06ee-2cd0-5652a4b1d019	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4476-0	2024-06-14	C162847	48780-1	f386c649-cd71-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use RESTASIS ® 0.05% safely and effectively. See full prescribing information for RESTASIS ® . RESTASIS ® ( cyclosporine ophthalmic emulsion ) 0.05% For topical ophthalmic use Initial U.S. Approval: 1983
50090-4476-0	2023-01-30	C162847	48780-1	f386c649-cd71-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use RESTASIS ® 0.05% safely and effectively. See full prescribing information for RESTASIS ® . RESTASIS ® ( cyclosporine ophthalmic emulsion ) 0.05% For topical ophthalmic use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4476-0	RESTASIS	.4 mL in 1 VIAL, SINGLE-USE	EMULSION	.4		21
50090-4476-0	RESTASIS	30 in 1 TRAY	EMULSION	30		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4476-0	EA - Each	50090-4476	c2a504b7-eac7-4c07-aba5-ed897ab2b63d	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4476	RESTASIS (CYCLOSPORINE) EMULSION [A-S MEDICATION SOLUTIONS]	21	Current NDC, Legacy NDC, 2 package rows	20240615_ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03.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
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 ndc (package): 50090-4476-0 ndc (product): 50090-4476 ndc11 (package): 50090447600

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
83HN0GTJ6D	CYCLOSPORINE	59865-13-3	CYCLOSPORINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2572292	cycloSPORINE 0.05 % in 0.4 ML Ophthalmic Emulsion	PSN	ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03	21
2572293	Restasis 0.05 % in 0.4 ML Ophthalmic Emulsion	PSN	ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03	21
2572293	0.4 ML cyclosporine 0.5 MG/ML Ophthalmic Suspension [Restasis]	SBD	ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03	21
2572292	0.4 ML cyclosporine 0.5 MG/ML Ophthalmic Suspension	SCD	ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03	21
2572293	0.4 ML Restasis 0.5 MG/ML Ophthalmic Suspension	SY	ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03	21
2572292	cyclosporine 0.05 % per 0.4 ML Ophthalmic Emulsion	SY	ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03	21
2572292	cyclosporine 0.5 MG/ML per 0.4 ML Ophthalmic Emulsion	SY	ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03	21
2572293	Restasis 0.05 % per 0.4 ML Ophthalmic Suspension	SY	ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4476-0	50090447600	30 VIAL, SINGLE-USE in 1 TRAY (50090-4476-0) / .4 mL in 1 VIAL, SINGLE-USE	2019-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RESTASIS - A-S Medication Solutions	A-S Medication Solutions	2024-05-24	HUMAN PRESCRIPTION DRUG LABEL	21