National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 02:33:29

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0023-9163-60	EA - Each	0023-9163	ba8da38d-8626-4f4d-b00e-0c18f8222f3a	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0023-9163	0023-9163-60

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 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
2026-10-15 13:18:30	2026-09	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050790-001	RESTASIS	0.05%	EMULSION / OPHTHALMIC	AB	RLD, RS	2002-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050790-002	RESTASIS MULTIDOSE	0.05%	EMULSION / OPHTHALMIC		RLD, RS	2016-10-27	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N050790-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050790-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050790-001	AB	1	`caaa826d4ba7…`
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 · 440 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N050790-002	8292129	2031-02-25		Drug product, Delist requested	2017-06-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050790-002	8561859	2032-04-16		Drug product, Delist requested	2017-06-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050790-002	9676525	2034-02-07		Drug product, Delist requested	2017-06-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050790-002	9669974	2034-05-11		Drug product, Delist requested	2017-06-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050790-002	8292129	2031-02-25		Drug product, Delist requested	2017-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050790-002	8561859	2032-04-16		Drug product, Delist requested	2017-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050790-002	9676525	2034-02-07		Drug product, Delist requested	2017-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050790-002	9669974	2034-05-11		Drug product, Delist requested	2017-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050790-002	8292129	2031-02-25		Drug product, Delist requested	2017-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050790-002	8561859	2032-04-16		Drug product, Delist requested	2017-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050790-002	9676525	2034-02-07		Drug product, Delist requested	2017-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050790-002	9669974	2034-05-11		Drug product, Delist requested	2017-06-26	`caaa826d4ba7…`
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…`

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
RESTASIS	CYCLOSPORINE	Allergan, Inc.	8e24af2b-bc1c-4849-94f2-6df950cdca89	2024-09-09	Warnings, Adverse reactions	Exact identifier ndc (package): 0023-9163-60 ndc11 (package): 00023916360

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.