Home NDC 0065-0665 Iopidine
Product NDC 0065-0665
11-digit product format 000650665
Labeler code 0065
Product ID 0065-0665_b7047404-8fe5-45cd-bfed-aec199fe8c4f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name apraclonidine
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application NDA020258
Marketing category NDA
Marketing start 1993-10-01
Marketing end 0000-00-00
Substance APRACLONIDINE HYDROCHLORIDE
Active strength 5 mg/mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 N020258-001 IOPIDINE APRACLONIDINE HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020258-001 AT
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 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020258-001 IOPIDINE EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded APRACLONIDINE HYDROCHLORIDE ACTIVE INGREDIENT D2VW67N38H IOPIDINE (APRACLONIDINE) SOLUTION [ALCON LABORATORIES, INC.] 2 APRACLONIDINE ACTIVE MOIETY 843CEN85DI IOPIDINE (APRACLONIDINE) SOLUTION [ALCON LABORATORIES, INC.] 2 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 IOPIDINE (APRACLONIDINE) SOLUTION [ALCON LABORATORIES, INC.] 2 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB IOPIDINE (APRACLONIDINE) SOLUTION [ALCON LABORATORIES, INC.] 2 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B IOPIDINE (APRACLONIDINE) SOLUTION [ALCON LABORATORIES, INC.] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X IOPIDINE (APRACLONIDINE) SOLUTION [ALCON LABORATORIES, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IOPIDINE (APRACLONIDINE) SOLUTION [ALCON LABORATORIES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R IOPIDINE (APRACLONIDINE) SOLUTION [ALCON LABORATORIES, INC.] 2
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.