Zerviate

Product NDC: 71776-024
11-digit product format: 717760024
Labeler code: 71776
Product ID: 71776-024_ec80e400-7e79-45ba-e053-2a95a90a18ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cetirizine
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Eyevance Pharmaceuticals
Application: NDA208694
Marketing category: NDA
Marketing start: 2019-02-19
Marketing end: 0000-00-00
Substance: CETIRIZINE
Active strength: 2 mg/mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71776-024		I	Inactivated by FDA	2026-08-03
excluded package	package	71776-024	71776-024-01	I	Inactivated by FDA	2026-08-03
excluded package	package	71776-024	71776-024-05	I	Inactivated by FDA	2026-08-03
excluded package	package	71776-024	71776-024-30	I	Inactivated by FDA	2026-08-03

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71776-024-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71776-024-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71776-024-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71776-024-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71776-024-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71776-024-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71776-024-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71776-024-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71776-024-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71776-024-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71776-024-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71776-024-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71776-024-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71776-024-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71776-024-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71776-024-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71776-024-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71776-024-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71776-024-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71776-024-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71776-024-05	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71776-024-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71776-024-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71776-024-05	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71776-024-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71776-024-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71776-024-05	U	Excluded because listing certification expired	`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
N208694-001	ZERVIATE	CETIRIZINE HYDROCHLORIDE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2017-05-30

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
N208694-001	8829005	2030-03-15	U-1680		2017-06-23
N208694-001	9750684	2030-03-15		Drug product	2017-09-14
N208694-001	9993471	2030-03-15	U-1680		2018-07-03
N208694-001	8829005*PED	2030-09-15		Pediatric extension
N208694-001	9254286	2032-07-09		Drug product	2017-06-23
N208694-001	9254286*PED	2033-01-09		Pediatric extension

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 246 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	N208694-001	8829005	2030-03-15	U-1680		2017-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208694-001	9750684	2030-03-15		Drug product	2017-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208694-001	9993471	2030-03-15	U-1680		2018-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208694-001	8829005*PED	2030-09-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208694-001	9254286	2032-07-09		Drug product	2017-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208694-001	9254286*PED	2033-01-09		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208694-001	8829005	2030-03-15	U-1680		2017-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208694-001	9750684	2030-03-15		Drug product	2017-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208694-001	9993471	2030-03-15	U-1680		2018-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208694-001	8829005*PED	2030-09-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208694-001	9254286	2032-07-09		Drug product	2017-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208694-001	9254286*PED	2033-01-09		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208694-001	8829005	2030-03-15	U-1680		2017-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208694-001	9750684	2030-03-15		Drug product	2017-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208694-001	9993471	2030-03-15	U-1680		2018-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208694-001	8829005*PED	2030-09-15		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208694-001	9254286	2032-07-09		Drug product	2017-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208694-001	9254286*PED	2033-01-09		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208694-001	8829005	2030-03-15	U-1680		2017-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208694-001	9750684	2030-03-15		Drug product	2017-09-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208694-001	9993471	2030-03-15	U-1680		2018-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208694-001	8829005*PED	2030-09-15		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208694-001	9254286	2032-07-09		Drug product	2017-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208694-001	9254286*PED	2033-01-09		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208694-001	8829005	2030-03-15	U-1680		2017-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208694-001	9750684	2030-03-15		Drug product	2017-09-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208694-001	9993471	2030-03-15	U-1680		2018-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208694-001	8829005*PED	2030-09-15		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208694-001	9254286	2032-07-09		Drug product	2017-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208694-001	9254286*PED	2033-01-09		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208694-001	8829005	2030-03-15	U-1680		2017-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208694-001	9750684	2030-03-15		Drug product	2017-09-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208694-001	9993471	2030-03-15	U-1680		2018-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208694-001	8829005*PED	2030-09-15		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208694-001	9254286	2032-07-09		Drug product	2017-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208694-001	9254286*PED	2033-01-09		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208694-001	8829005	2030-03-15	U-1680		2017-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208694-001	9750684	2030-03-15		Drug product	2017-09-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208694-001	9993471	2030-03-15	U-1680		2018-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208694-001	8829005*PED	2030-09-15		Pediatric extension		`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208694-001	NDF	2020-05-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208694-001	PED	2020-11-30	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N208694-001	NDF	2020-05-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208694-001	PED	2020-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208694-001	NDF	2020-05-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208694-001	PED	2020-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208694-001	NDF	2020-05-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208694-001	PED	2020-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208694-001	NDF	2020-05-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208694-001	PED	2020-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208694-001	NDF	2020-05-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208694-001	PED	2020-11-30	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71776-024-01	2025-01-30	C162847	48780-1	2cef2736-7890-d83d-e063-dadaa90ab31f	ZERVIATE™ (cetirizine ophthalmic solution) 0.24%, for topical ophthalmic use These highlights do not include all the information needed to use ZERVIATE safely and effectively. See full prescribing information for ZERVIATE. Initial U.S. Approval: 1995
71776-024-05	2025-01-30	C162847	48780-1	2cef2736-7890-d83d-e063-dadaa90ab31f	ZERVIATE™ (cetirizine ophthalmic solution) 0.24%, for topical ophthalmic use These highlights do not include all the information needed to use ZERVIATE safely and effectively. See full prescribing information for ZERVIATE. Initial U.S. Approval: 1995
71776-024-30	2025-01-30	C162847	48780-1	2cef2736-7890-d83d-e063-dadaa90ab31f	ZERVIATE™ (cetirizine ophthalmic solution) 0.24%, for topical ophthalmic use These highlights do not include all the information needed to use ZERVIATE safely and effectively. See full prescribing information for ZERVIATE. Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71776-024-01	Zerviate	0.2 mL in 1 VIAL, SINGLE-USE	SOLUTION/ DROPS	0.2	11
71776-024-01	Zerviate	5 in 1 CARTON	SOLUTION/ DROPS	5	11
71776-024-05	Zerviate	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	11
71776-024-05	Zerviate	1 in 1 CARTON	SOLUTION/ DROPS	1	11
71776-024-30	Zerviate	0.2 mL in 1 VIAL, SINGLE-USE	SOLUTION/ DROPS	0.2	11
71776-024-30	Zerviate	30 in 1 CARTON	SOLUTION/ DROPS	30	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71776-024-30	EA - Each	71776-024	830d981c-7cf9-4966-ab5b-44b9c678bb48	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71776-024	ZERVIATE (CETIRIZINE) SOLUTION/ DROPS [EYEVANCE PHARMACEUTICALS]	11	Legacy NDC, 6 package rows	20231010_3e6fecc1-df71-4c01-a654-f55635617a7f.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
ZERVIATE	CETIRIZINE	Harrow Eye, LLC	6fc5ef4e-4aea-4c34-8d51-0c07ab9aad59	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208694 application number: NDA208694

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YO7261ME24	CETIRIZINE	83881-51-0	CETIRIZINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2119476	cetirizine 0.24 % Ophthalmic Solution	PSN	3e6fecc1-df71-4c01-a654-f55635617a7f	11
2119481	ZERVIATE 0.24 % Ophthalmic Solution	PSN	3e6fecc1-df71-4c01-a654-f55635617a7f	11
2119481	cetirizine 2.4 MG/ML Ophthalmic Solution [Zerviate]	SBD	3e6fecc1-df71-4c01-a654-f55635617a7f	11
2119476	cetirizine 2.4 MG/ML Ophthalmic Solution	SCD	3e6fecc1-df71-4c01-a654-f55635617a7f	11
2119476	cetirizine 0.24 % Ophthalmic Solution	SY	3e6fecc1-df71-4c01-a654-f55635617a7f	11
2119476	cetirizine 2.4 MG (as cetirizine HCl 2.85 MG) per 1 ML Ophthalmic Solution	SY	3e6fecc1-df71-4c01-a654-f55635617a7f	11
2119481	Zerviate 0.24 % Ophthalmic Solution	SY	3e6fecc1-df71-4c01-a654-f55635617a7f	11
2119481	Zerviate 2.4 MG/ML Ophthalmic Solution	SY	3e6fecc1-df71-4c01-a654-f55635617a7f	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71776-024-01	71776002401	5 VIAL, SINGLE-USE in 1 CARTON (71776-024-01) > .2 mL in 1 VIAL, SINGLE-USE	2020-03-23	0000-00-00	No	No	Current
71776-024-05	71776002405	1 BOTTLE, DROPPER in 1 CARTON (71776-024-05) > 5 mL in 1 BOTTLE, DROPPER	2019-02-19	0000-00-00	No	No	Current
71776-024-30	71776002430	30 VIAL, SINGLE-USE in 1 CARTON (71776-024-30) > .2 mL in 1 VIAL, SINGLE-USE	2020-03-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zerviate	Eyevance Pharmaceuticals \| Excelvision \| COSMA Spa	2023-10-09	HUMAN PRESCRIPTION DRUG LABEL	11