Flurbiprofen Sodium
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Flurbiprofen Sodium
- Generic name
- FLURBIPROFEN SODIUM
- Manufacturer
- Amici Pharma, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- c27f2d57-4b9d-4b78-8d85-3bac84f733b1
- SPL ID
- 1ec17137-cc34-44e9-b03f-efcafeb0fe05
- Version
- 6
- Effective date
- 2026-04-14
- Source export date
- 2026-09-28
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:06:29
| Harmonized routes |
|---|
| OPHTHALMIC |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 074447 | derived:openfda.application_number |
| application number | ANDA074447 | openfda.application_number | |
| brand name | Flurbiprofen Sodium | openfda.brand_name | |
| generic name | FLURBIPROFEN SODIUM | openfda.generic_name | |
| manufacturer name | Amici Pharma, Inc. | openfda.manufacturer_name | |
| ndc | package | 69292-722-25 | openfda.package_ndc |
| ndc | product | 69292-722 | openfda.product_ndc |
| ndc11 | package | 69292072225 | derived:openfda.package_ndc |
| rxcui | 1243585 | openfda.rxcui | |
| spl id | 1ec17137-cc34-44e9-b03f-efcafeb0fe05 | id | |
| spl set id | c27f2d57-4b9d-4b78-8d85-3bac84f733b1 | set_id | |
| unii | Z5B97MU9K4 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS With some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that flurbiprofen sodium ophthalmic solution may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. There is the potential for cross-sensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of flurbiprofen sodium ophthalmic solution. Other adverse reactions reported with the use of flurbiprofen sodium ophthalmic solution include: fibrosis, hyphema, miosis, mydriasis, and ocular hyperemia. Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported (see Warnings ). To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.