FDA.reportPublic FDA data

bromfenac

Product NDC
50383-249
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

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-249-712024-01-30C16284748780-11030e365-47b2-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Bromfenac Ophthalmic Solution safely and effectively. See full prescribing information for bromfenac. Initial U.S. Approval: 1997

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMFENAC SODIUMACTIVE INGREDIENT8ECV571Y37BROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]3
BROMFENACACTIVE MOIETY864P0921DWBROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]3
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4BROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XBROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]3
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOBROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]3
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GBROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RBROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]3

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

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