FDA.reportPublic FDA data

BROMFENAC SODIUM

Product NDC
46708-583
11-digit product format
467080583
Labeler code
46708
Product ID
46708-583_f66f1436-daaa-412a-8822-c64866cfeada
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BROMFENAC SODIUM
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA214340
Marketing category
ANDA
Marketing start
2024-07-08
Substance
BROMFENAC SODIUM
Active strength
.805 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

Additional Listing Data#

Finished product
Yes
Brand name base
BROMFENAC SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMFENAC SODIUM.805 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ECV571Y37
Rxcui1375917

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-583-03BROMFENAC SODIUM1 in 1 CARTONSOLUTION/ DROPS11
46708-583-03BROMFENAC SODIUM03 mL in 1 BOTTLESOLUTION/ DROPS031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-583BROMFENAC SODIUM SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20240710_f66f1436-daaa-412a-8822-c64866cfeada.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1375917bromfenac 0.07 % Ophthalmic SolutionPSNf66f1436-daaa-412a-8822-c64866cfeada1
1375917bromfenac 0.7 MG/ML Ophthalmic SolutionSCDf66f1436-daaa-412a-8822-c64866cfeada1
1375917bromfenac 0.07 % Ophthalmic SolutionSYf66f1436-daaa-412a-8822-c64866cfeada1
1375917bromfenac 0.7 MG/ML (as bromfenac sodium 0.805 MG/ML) Ophthalmic SolutionSYf66f1436-daaa-412a-8822-c64866cfeada1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-583-03467080583031 BOTTLE in 1 CARTON (46708-583-03) / 3 mL in 1 BOTTLE1 bottle2024-07-08NoNoCurrent