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

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