Home NDC 71776-100 Flarex
Product NDC 71776-100
11-digit product format 717760100
Labeler code 71776
Product ID 71776-100_2bed0334-e39e-c18b-e063-6294a90af598
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluorometholone acetate
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Eyevance Pharmaceuticals
Application NDA019079
Marketing category NDA
Marketing start 2019-03-05
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 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 71776-100 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71776-100 71776-100-03 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71776-100 71776-100-05 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 71776-100-03 Flarex 1 in 1 CARTON SUSPENSION/ DROPS 1 7 71776-100-03 Flarex 2.5 mL in 1 BOTTLE, PLASTIC SUSPENSION/ DROPS 2.5 7 71776-100-05 Flarex 5 mL in 1 BOTTLE, PLASTIC SUSPENSION/ DROPS 5 7 71776-100-05 Flarex 1 in 1 CARTON SUSPENSION/ DROPS 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71776-100 FLAREX (FLUOROMETHOLONE ACETATE) SUSPENSION/ DROPS [EYEVANCE PHARMACEUTICALS] 7 Current NDC, Legacy NDC, 4 package rows 20250119_19918ea5-8568-44d6-b8ee-7b2197cee85c.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 Marketing end Sample Exclude flag Status 71776-100-03 71776010003 1 BOTTLE, PLASTIC in 1 CARTON (71776-100-03) / 2.5 mL in 1 BOTTLE, PLASTIC 2022-01-01 0000-00-00 Yes No Current 71776-100-05 71776010005 1 BOTTLE, PLASTIC in 1 CARTON (71776-100-05) / 5 mL in 1 BOTTLE, PLASTIC 2019-03-05 0000-00-00 No No Current