Home NDC 61314-665 Apraclonidine
Product NDC 61314-665
11-digit product format 613140665
Labeler code 61314
Product ID 61314-665_238af96f-2f89-9af4-e063-6394a90a9516
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Apraclonidine
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Sandoz Inc
Application NDA020258
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2009-07-19
Substance APRACLONIDINE HYDROCHLORIDE
Active strength 5.75 mg/mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [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 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.
Additional Listing Data#
Finished product Yes
Brand name base Apraclonidine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength APRACLONIDINE HYDROCHLORIDE 5.75 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308345 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 61314-665-05 Apraclonidine 5 mL in 1 BOTTLE SOLUTION 5 8 61314-665-10 Apraclonidine 10 mL in 1 BOTTLE SOLUTION 10 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded APRACLONIDINE HYDROCHLORIDE ACTIVE INGREDIENT D2VW67N38H APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 5 APRACLONIDINE ACTIVE MOIETY 843CEN85DI APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 5 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 5 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 5 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 5 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 5 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61314-665 APRACLONIDINE SOLUTION [SANDOZ INC] 8 Current NDC, Legacy NDC, 2 package rows 20241009_04ad82af-e7ba-4f40-a120-be9d33cf0c7b.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 Marketing end Sample Exclude flag Status 61314-665-05 61314066505 5 mL in 1 BOTTLE (61314-665-05) 5 ml 2009-07-19 0000-00-00 No No Current 61314-665-10 61314066510 10 mL in 1 BOTTLE (61314-665-10) 10 ml 2009-07-19 0000-00-00 No No Current