Bromday

Product NDC
50436-6301
11-digit product format
504366301
Labeler code
50436
Product ID
50436-6301_323f622f-6ffb-4557-af9d-4ef6f40541e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bromfenac
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Unit Dose Services
Application
NDA021664
Marketing category
NDA
Marketing start
2010-09-20
Marketing end
0000-00-00
Substance
BROMFENAC SODIUM
Active strength
1 mg/mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50436-6301IInactivated by FDA2026-08-03
excluded packagepackage50436-630150436-6301-0IInactivated 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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-6301-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-6301-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-6301-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-6301-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-6301-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-6301-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-6301-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-6301-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-6301-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-6301-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-6301-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-6301-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-6301-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-6301-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-6301-01332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50436-6301-0fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50436-6301-086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50436-6301-0bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50436-6301-08dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50436-6301-0e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50436-6301-09bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021664-001XIBROMBROMFENAC SODIUMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-24
N021664-002BROMDAYBROMFENAC SODIUMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-16

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021664-001XIBROMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICRLD2005-03-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021664-002BROMDAYEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICRLD2010-10-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021664-001XIBROMEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICRLD2005-03-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021664-002BROMDAYEQ 0.09% ACIDSOLUTION/DROPS / OPHTHALMICRLD2010-10-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-24782e0a99824c…
2021-12-28 21:50 UTC2021-12N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-16782e0a99824c…

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
50436-6301-0Bromday1.7 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1.72

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6301BROMDAY (BROMFENAC) SOLUTION/ DROPS [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20131007_234a2447-90a7-4b8a-a344-7eef1e5daa6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020510Bromday 0.09 % Ophthalmic SolutionPSN234a2447-90a7-4b8a-a344-7eef1e5daa6a2
578018bromfenac 0.09 % Ophthalmic SolutionPSN234a2447-90a7-4b8a-a344-7eef1e5daa6a2
1020510bromfenac 0.9 MG/ML Ophthalmic Solution [Bromday]SBD234a2447-90a7-4b8a-a344-7eef1e5daa6a2
578018bromfenac 0.9 MG/ML Ophthalmic SolutionSCD234a2447-90a7-4b8a-a344-7eef1e5daa6a2
1020510Bromday 0.09 % Ophthalmic SolutionSY234a2447-90a7-4b8a-a344-7eef1e5daa6a2
578018bromfenac 0.09 % Ophthalmic SolutionSY234a2447-90a7-4b8a-a344-7eef1e5daa6a2
578018bromfenac 0.9 MG/ML (bromfenac sodium 1.035 MG/ML) Ophthalmic SolutionSY234a2447-90a7-4b8a-a344-7eef1e5daa6a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50436-6301-0504366301001.7 mL in 1 BOTTLE, DROPPER1.7 mlHistorical