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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074447-001FLURBIPROFEN SODIUMFLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICAT1995-01-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICAT1995-01-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICAT1995-01-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICAT1995-01-043f01610625f2…
2019-09-15 20:21 UTC2019-09A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICAT1995-01-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICAT1995-01-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074447-001FLURBIPROFEN SODIUM0.03%SOLUTION/DROPS / OPHTHALMICRS1995-01-04cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A074447-001AT174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A074447-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074447-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074447-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A074447-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074447-001AT1ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Flurbiprofen Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLURBIPROFEN SODIUM.3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z5B97MU9K4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1243585Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
11db354f-caf9-4567-811e-6c9beb1330c7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
4de25cad-9156-ffae-eb2b-85736b333948Product name220201015
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
4d57173b-5512-6c00-533c-5ed2a40fc5b8Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-314-25Flurbiprofen Sodium2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.57
24208-314-25Flurbiprofen Sodium1 in 1 CARTONSOLUTION/ DROPS17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-314-25ML - Milliliter24208-314543f1485-9fb8-450b-b47c-477d25b7e39712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLURBIPROFEN SODIUMACTIVE INGREDIENTZ5B97MU9K4FLURBIPROFEN SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
FLURBIPROFENACTIVE MOIETY5GRO578KLPFLURBIPROFEN SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFLURBIPROFEN SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFLURBIPROFEN SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFLURBIPROFEN SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990FLURBIPROFEN SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10FLURBIPROFEN SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLURBIPROFEN SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRFLURBIPROFEN SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLURBIPROFEN SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
THIMEROSALINACTIVE INGREDIENT2225PI3MOVFLURBIPROFEN SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
WATERINACTIVE INGREDIENT059QF0KO0RFLURBIPROFEN SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
Flurbiprofen SodiumACTIVE INGREDIENTZ5B97MU9K4FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
FLURBIPROFENACTIVE MOIETY5GRO578KLPFLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
Citric AcidINACTIVE INGREDIENT2968PHW8QPFLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KFLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBFLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
Potassium ChlorideINACTIVE INGREDIENT660YQ98I10FLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XFLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRFLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IFLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
ThimerosalINACTIVE INGREDIENT2225PI3MOVFLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RFLURBIPROFEN SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-314FLURBIPROFEN SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7Current NDC, Legacy NDC, 2 package rows20240725_11db354f-caf9-4567-811e-6c9beb1330c7.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flurbiprofen SodiumFLURBIPROFEN SODIUMAmici Pharma, Inc.c27f2d57-4b9d-4b78-8d85-3bac84f733b12026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074447
application number: ANDA074447
Flurbiprofen SodiumFLURBIPROFEN SODIUMBausch & Lomb Incorporated11db354f-caf9-4567-811e-6c9beb1330c72024-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074447
application number: ANDA074447
ndc (product): 24208-314
Flurbiprofen SodiumFLURBIPROFEN SODIUMA-S Medication Solutions9243ed05-1f7b-43ee-82c3-572a4112ae092023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074447
application number: ANDA074447
Flurbiprofen SodiumFLURBIPROFEN SODIUMProficient Rx LP8c5247a4-6388-44f4-8a47-3de5e7c5b1692019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074447
application number: ANDA074447

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243585flurbiprofen sodium 0.03 % Ophthalmic SolutionPSN11db354f-caf9-4567-811e-6c9beb1330c77
1243585flurbiprofen sodium 0.3 MG/ML Ophthalmic SolutionSCD11db354f-caf9-4567-811e-6c9beb1330c77
1243585flurbiprofen sodium 0.03 % Ophthalmic SolutionSY11db354f-caf9-4567-811e-6c9beb1330c77
1243585flurbiprofen sodium 0.03 % Ophthalmic SolutionPSN8c5247a4-6388-44f4-8a47-3de5e7c5b1693
1243585flurbiprofen sodium 0.3 MG/ML Ophthalmic SolutionSCD8c5247a4-6388-44f4-8a47-3de5e7c5b1693
1243585flurbiprofen sodium 0.03 % Ophthalmic SolutionSY8c5247a4-6388-44f4-8a47-3de5e7c5b1693
1243585flurbiprofen sodium 0.03 % Ophthalmic SolutionPSN725fb4ac-3bd2-4c0f-829f-a3a40863ebce1
1243585flurbiprofen sodium 0.3 MG/ML Ophthalmic SolutionSCD725fb4ac-3bd2-4c0f-829f-a3a40863ebce1
1243585flurbiprofen sodium 0.03 % Ophthalmic SolutionSY725fb4ac-3bd2-4c0f-829f-a3a40863ebce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-314-25242080314251 BOTTLE, DROPPER in 1 CARTON (24208-314-25) / 2.5 mL in 1 BOTTLE, DROPPER1995-01-040000-00-00NoNoCurrent