Flurbiprofen Sodium
- Product NDC
- 24208-314
- 11-digit product format
- 242080314
- Labeler code
- 24208
- Product ID
- 24208-314_1e00e938-a04a-4192-e063-6394a90a75a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Flurbiprofen Sodium
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Bausch & Lomb Incorporated
- Application
- ANDA074447
- Marketing category
- ANDA
- Marketing start
- 1995-01-04
- 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| 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.
| 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#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A074447-001 | AT | 1 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | A074447-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A074447-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A074447-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A074447-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A074447-001 | AT | 1 | ea99ee380514… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Flurbiprofen Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FLURBIPROFEN SODIUM | .3 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| Z5B97MU9K4 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1243585 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 11db354f-caf9-4567-811e-6c9beb1330c7 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 24208-314-25 | Flurbiprofen Sodium | 2.5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2.5 | 7 | |
| 24208-314-25 | Flurbiprofen Sodium | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24208-314-25 | ML - Milliliter | 24208-314 | 543f1485-9fb8-450b-b47c-477d25b7e397 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Flurbiprofen Sodium | FLURBIPROFEN SODIUM | Amici Pharma, Inc. | c27f2d57-4b9d-4b78-8d85-3bac84f733b1 | 2026-04-14 | Warnings, Adverse reactions | 074447 ANDA074447 |
| Flurbiprofen Sodium | FLURBIPROFEN SODIUM | Bausch & Lomb Incorporated | 11db354f-caf9-4567-811e-6c9beb1330c7 | 2024-07-24 | Warnings, Adverse reactions | 074447 ANDA074447 24208-314 |
| Flurbiprofen Sodium | FLURBIPROFEN SODIUM | A-S Medication Solutions | 9243ed05-1f7b-43ee-82c3-572a4112ae09 | 2023-02-06 | Warnings, Adverse reactions | 074447 ANDA074447 |
| Flurbiprofen Sodium | FLURBIPROFEN SODIUM | Proficient Rx LP | 8c5247a4-6388-44f4-8a47-3de5e7c5b169 | 2019-11-01 | Warnings, Adverse reactions | 074447 ANDA074447 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1243585 | flurbiprofen sodium 0.03 % Ophthalmic Solution | PSN | 11db354f-caf9-4567-811e-6c9beb1330c7 | 7 |
| 1243585 | flurbiprofen sodium 0.3 MG/ML Ophthalmic Solution | SCD | 11db354f-caf9-4567-811e-6c9beb1330c7 | 7 |
| 1243585 | flurbiprofen sodium 0.03 % Ophthalmic Solution | SY | 11db354f-caf9-4567-811e-6c9beb1330c7 | 7 |
| 1243585 | flurbiprofen sodium 0.03 % Ophthalmic Solution | PSN | 8c5247a4-6388-44f4-8a47-3de5e7c5b169 | 3 |
| 1243585 | flurbiprofen sodium 0.3 MG/ML Ophthalmic Solution | SCD | 8c5247a4-6388-44f4-8a47-3de5e7c5b169 | 3 |
| 1243585 | flurbiprofen sodium 0.03 % Ophthalmic Solution | SY | 8c5247a4-6388-44f4-8a47-3de5e7c5b169 | 3 |
| 1243585 | flurbiprofen sodium 0.03 % Ophthalmic Solution | PSN | 725fb4ac-3bd2-4c0f-829f-a3a40863ebce | 1 |
| 1243585 | flurbiprofen sodium 0.3 MG/ML Ophthalmic Solution | SCD | 725fb4ac-3bd2-4c0f-829f-a3a40863ebce | 1 |
| 1243585 | flurbiprofen sodium 0.03 % Ophthalmic Solution | SY | 725fb4ac-3bd2-4c0f-829f-a3a40863ebce | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 24208-314-25 | 24208031425 | 1 BOTTLE, DROPPER in 1 CARTON (24208-314-25) / 2.5 mL in 1 BOTTLE, DROPPER | 1995-01-04 | 0000-00-00 | No | No | Current |