Home NDC 71776-100-03 Flarex
Product NDC 71776-100
Requested package NDC 71776-100-03
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# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 1 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
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 package package 71776-100 71776-100-03 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…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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
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