bromfenac

Product NDC
50383-249
Requested package NDC
50383-249-71
11-digit product format
503830249
Labeler code
50383
Product ID
50383-249_835249a6-2d83-4ecd-b2a4-4539e2f8709d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bromfenac
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA203395
Marketing category
ANDA
Marketing start
2014-01-22
Marketing end
0000-00-00
Substance
BROMFENAC SODIUM
Active strength
1 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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50383-24950383-249-71IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A203395-001BROMFENAC SODIUMBROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A203395-001AT2

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 UTC2026-02A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-223f01610625f2…
2019-09-15 20:21 UTC2019-09A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT22014-01-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203395-001BROMFENAC SODIUMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICAT2RS2014-01-22cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203395-001AT21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203395-001AT2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203395-001AT216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203395-001AT21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203395-001AT21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203395-001AT2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203395-001AT212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203395-001AT215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203395-001AT21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203395-001AT21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203395-001AT2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203395-001AT21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203395-001AT211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203395-001AT218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203395-001AT215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203395-001AT215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203395-001AT214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203395-001AT2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203395-001AT21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203395-001AT21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203395-001AT2187673890dc5c…
2021-03-12 10:30 UTC2021-03A203395-001AT215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203395-001AT218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203395-001AT21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203395-001AT213f01610625f2…
2019-09-15 20:21 UTC2019-09A203395-001AT21b00525d2431f…
2019-07-19 19:46 UTC2019-07A203395-001AT21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203395-001AT216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203395-001AT211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203395-001AT21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203395-001AT21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203395-001AT219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203395-001AT21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203395-001AT213f0d92c62455…
2023-05-13 08:27 UTC2023-05A203395-001AT21053a50430f4f…
2023-01-26 05:58 UTC2023-01A203395-001AT213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203395-001AT213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203395-001AT21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203395-001AT21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203395-001AT21cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e42b5738-f3b2-36cb-547c-d658794618bcProduct name220250804
4ce8f27b-067c-45ad-b8f6-4b29ec66e497Product name220250115
b81a1117-443d-49e4-a709-58c3c32468afProduct name520241010
ee6f8cae-1597-1a7e-3fb9-6aaeba954efeProduct name320150902
8442aba0-7521-47cb-8a4e-c9896f35e8aeProduct name320150317

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-249-71bromfenac1 in 1 CARTONSOLUTION/ DROPS18
50383-249-71bromfenac1.7 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1.78

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-249-71ML - Milliliter50383-2493ab22a0b-8050-4752-bbba-1bdeab13b23112014-02-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-249BROMFENAC SOLUTION/ DROPS [AKORN]8Legacy NDC, 2 package rows20220312_e853723e-8419-4444-89e9-ee3f571b0974.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BromfenacBROMFENACARMAS PHARMACEUTICALS INC.08a0591e-6cb3-30ce-e063-6394a90a33fb2023-10-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203395
application number: ANDA203395

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
578018bromfenac 0.09 % Ophthalmic SolutionPSNe853723e-8419-4444-89e9-ee3f571b09748
578018bromfenac 0.9 MG/ML Ophthalmic SolutionSCDe853723e-8419-4444-89e9-ee3f571b09748
578018bromfenac 0.09 % Ophthalmic SolutionSYe853723e-8419-4444-89e9-ee3f571b09748
578018bromfenac 0.9 MG/ML (bromfenac sodium 1.035 MG/ML) Ophthalmic SolutionSYe853723e-8419-4444-89e9-ee3f571b09748

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50383-249-71503830249711 BOTTLE, DROPPER in 1 CARTON (50383-249-71) > 1.7 mL in 1 BOTTLE, DROPPER2014-01-220000-00-00NoNoCurrent