Home NDC 0065-0660 IOPIDINE
Product NDC 0065-0660
11-digit product format 000650660
Labeler code 0065
Product ID 0065-0660_1476ec41-31c3-4848-9bfd-8899fa302fc2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name apraclonidine hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application NDA019779
Marketing category NDA
Marketing start 1988-05-15
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0065-0660-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0065-0660-10 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0065-0660-10 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0065-0660-10 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0065-0660-10 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0065-0660-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0065-0660-10 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0065-0660-10 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0065-0660-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0065-0660-10 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0065-0660-10 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0065-0660-10 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0065-0660-10 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0065-0660-10 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0065-0660-10 1332a3947898…d4bfe170f9cd…
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…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0065-0660-10 IOPIDINE 12 in 1 CARTON SOLUTION/ DROPS 12 11 0065-0660-10 IOPIDINE 2 in 1 POUCH SOLUTION/ DROPS 2 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded APRACLONIDINE HYDROCHLORIDE ACTIVE INGREDIENT D2VW67N38H IOPIDINE (APRACLONIDINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 4 APRACLONIDINE ACTIVE MOIETY 843CEN85DI IOPIDINE (APRACLONIDINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 4 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 IOPIDINE (APRACLONIDINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 4 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB IOPIDINE (APRACLONIDINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 4 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B IOPIDINE (APRACLONIDINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X IOPIDINE (APRACLONIDINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 4 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IOPIDINE (APRACLONIDINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R IOPIDINE (APRACLONIDINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-0660 IOPIDINE (APRACLONIDINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 11 Legacy NDC, 2 package rows 20211008_2a6c44a6-e415-467f-bf3b-3e7f2c7dc714.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
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 0065-0660-10 00065066010 12 POUCH in 1 CARTON (0065-0660-10) > 2 VIAL, SINGLE-USE in 1 POUCH > .1 mL in 1 VIAL, SINGLE-USE 12 pouch 1988-05-15 0000-00-00 No No Current