Home NDC 82667-300 IHEEZO
Product NDC 82667-300
11-digit product format 826670300
Labeler code 82667
Product ID 82667-300_4dc9b9f7-e722-51ce-e063-6394a90a5219
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name chloroprocaine hydrochloride ophthalmic gel
Dosage form GEL
Route OPHTHALMIC
Labeler Harrow Eye, LLC
Application NDA216227
Marketing category NDA
Marketing start 2022-09-27
Substance CHLOROPROCAINE HYDROCHLORIDE
Active strength 24 mg/800mg
Pharmacologic classes Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N216227-001 IHEEZO CHLOROPROCAINE HYDROCHLORIDE 3% GEL / OPHTHALMIC RLD, RS 2022-09-27
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 N216227-001 11969403 2039-05-14 Drug product 2025-02-07
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.
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 2026-08-18 06:07:40 2026-07 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216227-001 IHEEZO 3% GEL / OPHTHALMIC RLD, RS 2022-09-27 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216227-001 11969403 2039-05-14 Drug product 2025-02-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216227-001 11969403 2039-05-14 Drug product 2025-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216227-001 11969403 2039-05-14 Drug product 2025-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216227-001 11969403 2039-05-14 Drug product 2025-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216227-001 11969403 2039-05-14 Drug product 2025-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216227-001 11969403 2039-05-14 Drug product 2025-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 3a93d1ddd44b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216227-001 10792271 2038-09-15 U-3457 Drug product 2022-10-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216227-001 11969403 2039-05-14 Drug product 2025-02-07 a50c72e98297…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base IHEEZO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLOROPROCAINE HYDROCHLORIDE 24 mg/800mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LT7Z1YW11H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2613956 Internal RxNorm lookup 2613961 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82667-300 IHEEZO (CHLOROPROCAINE HYDROCHLORIDE OPHTHALMIC GEL) GEL [HARROW EYE, LLC] 2 Current NDC, Legacy NDC, 6 package rows 20230224_ea3b2d2c-8b33-d199-e053-2995a90a699c.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 IHEEZO CHLOROPROCAINE HYDROCHLORIDE OPHTHALMIC GEL Harrow Eye, LLC ea3b2d2c-8b33-d199-e053-2995a90a699c 2026-03-24 Warnings, Adverse reactions Exact identifier application applno (NDA): 216227 application number: NDA216227 ndc (product): 82667-300
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 82667-300-00 82667030000 1 POUCH in 1 CARTON (82667-300-00) / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL 1 pouch 2023-03-15 Yes No Current 82667-300-01 82667030001 1 POUCH in 1 CARTON (82667-300-01) / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL 1 pouch 2022-09-27 0000-00-00 No No Current 82667-300-05 82667030005 5 POUCH in 1 CARTON (82667-300-05) / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL 5 pouch 2026-03-02 No No Current