Home NDC 82667-010 Flarex
Product NDC 82667-010
11-digit product format 826670010
Labeler code 82667
Product ID 82667-010_31ac358e-0c93-1db8-e063-6294a90ae8e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluorometholone acetate
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Harrow Eye, LLC
Application NDA019079
Marketing category NDA
Marketing start 2025-03-31
Substance FLUOROMETHOLONE ACETATE
Active strength 1 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 N019079-001 FLAREX FLUOROMETHOLONE ACETATE 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11
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 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019079-001 FLAREX 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-02-11 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Flarex
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOROMETHOLONE ACETATE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9I50C3I3OK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1249629 Internal RxNorm lookup 1249631 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 82667-010-00 Flarex 2.5 mL in 1 BOTTLE, PLASTIC SUSPENSION/ DROPS 2.5 2 82667-010-00 Flarex 1 in 1 CARTON SUSPENSION/ DROPS 1 2 82667-010-01 Flarex 1 in 1 CARTON SUSPENSION/ DROPS 1 2 82667-010-01 Flarex 5 mL in 1 BOTTLE, PLASTIC SUSPENSION/ DROPS 5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82667-010 FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION/ DROPS [HARROW EYE, LLC] 2 Current NDC, 4 package rows 20250403_f060dec4-09dc-4266-ab4c-a6ed49cd8126.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82667-010-00 82667001000 1 BOTTLE, PLASTIC in 1 CARTON (82667-010-00) / 2.5 mL in 1 BOTTLE, PLASTIC 2025-03-31 Yes No Current 82667-010-01 82667001001 1 BOTTLE, PLASTIC in 1 CARTON (82667-010-01) / 5 mL in 1 BOTTLE, PLASTIC 2025-03-31 No No Current