Home NDC 82667-200 IOPIDINE 1%
Product NDC 82667-200
11-digit product format 826670200
Labeler code 82667
Product ID 82667-200_515542b6-cc36-ff77-e063-6294a90ad59e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name apraclonidine hydrochloride ophthalmic solution
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Harrow Eye, LLC
Application NDA019779
Marketing category NDA
Marketing start 2023-08-01
Substance APRACLONIDINE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
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 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 N019779-001 IOPIDINE APRACLONIDINE HYDROCHLORIDE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31
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 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base IOPIDINE 1%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength APRACLONIDINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D2VW67N38H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 211020 Internal RxNorm lookup 308346 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 82667-200-01 IOPIDINE 1% 12 in 1 CARTON SOLUTION/ DROPS 12 4 82667-200-01 IOPIDINE 1% 2 in 1 POUCH SOLUTION/ DROPS 2 4 82667-200-05 IOPIDINE 1% 5 in 1 CARTON SOLUTION/ DROPS 5 4 82667-200-05 IOPIDINE 1% 5 in 1 POUCH SOLUTION/ DROPS 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82667-200 IOPIDINE 1% (APRACLONIDINE HYDROCHLORIDE OPHTHALMIC SOLUTION) SOLUTION/ DROPS [HARROW EYE, LLC] 1 Current NDC, 4 package rows 20230801_00f18845-ccde-8678-e063-6294a90a3374.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 IOPIDINE 1% APRACLONIDINE HYDROCHLORIDE OPHTHALMIC SOLUTION Harrow Eye, LLC 00f18845-ccde-8678-e063-6294a90a3374 2026-05-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 019779 application number: NDA019779 ndc (product): 82667-200
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82667-200-01 82667020001 12 POUCH in 1 CARTON (82667-200-01) / 2 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE 12 pouch 2023-08-01 No No Current 82667-200-05 82667020005 5 POUCH in 1 CARTON (82667-200-05) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE 5 pouch 2026-05-01 No No Current