Home NDC 69292-722 Flurbiprofen Sodium
Product NDC 69292-722
11-digit product format 692920722
Labeler code 69292
Product ID 69292-722_1ec17137-cc34-44e9-b03f-efcafeb0fe05
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flurbiprofen Sodium
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Amici Pharma, Inc.
Application ANDA074447
Marketing category ANDA
Marketing start 2018-03-31
Substance FLURBIPROFEN SODIUM
Active strength .3 mg/mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A074447-001 FLURBIPROFEN SODIUM FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04
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 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC AT 1995-01-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC AT 1995-01-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC AT 1995-01-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC AT 1995-01-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC AT 1995-01-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC AT 1995-01-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074447-001 FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS / OPHTHALMIC RS 1995-01-04 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Flurbiprofen Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLURBIPROFEN SODIUM .3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Z5B97MU9K4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1243585 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 69292-722-25 Flurbiprofen Sodium 2.5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2.5 6 69292-722-25 Flurbiprofen Sodium 1 in 1 CARTON SOLUTION/ DROPS 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69292-722 FLURBIPROFEN SODIUM SOLUTION/ DROPS [AMICI PHARMACEUTICALS LLC] 5 Current NDC, Legacy NDC, 2 package rows 20240128_c27f2d57-4b9d-4b78-8d85-3bac84f733b1.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 · 4 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 69292-722-25 69292072225 1 BOTTLE, DROPPER in 1 CARTON (69292-722-25) / 2.5 mL in 1 BOTTLE, DROPPER 2018-03-31 0000-00-00 No No Current