Home NDC 82667-015 ZERVIATE
Product NDC 82667-015
11-digit product format 826670015
Labeler code 82667
Product ID 82667-015_33794d74-d742-82b5-e063-6294a90a6f32
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cetirizine
Dosage form FOR SOLUTION
Route OPHTHALMIC
Labeler Harrow Eye, LLC
Application NDA208694
Marketing category NDA
Marketing start 2025-04-30
Substance CETIRIZINE
Active strength 2.4 mg/mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 · 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 Product TE source text 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# Additional Listing Data#
Finished product Yes
Brand name base ZERVIATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETIRIZINE 2.4 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YO7261ME24 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2119476 Internal RxNorm lookup 2119481 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 82667-015-24 ZERVIATE 1 in 1 CARTON FOR SOLUTION 1 2 82667-015-24 ZERVIATE 30 in 1 POUCH FOR SOLUTION 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82667-015 ZERVIATE (CETIRIZINE) FOR SOLUTION [HARROW EYE, LLC] 2 Current NDC, 2 package rows 20250430_6fc5ef4e-4aea-4c34-8d51-0c07ab9aad59.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82667-015-24 82667001524 1 POUCH in 1 CARTON (82667-015-24) / 30 VIAL, SINGLE-USE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-USE 1 pouch 2025-04-30 No No Current