FDA.reportPublic FDA data

bromfenac

Product NDC
49708-755
11-digit product format
497080755
Labeler code
49708
Product ID
49708-755_47dae14d-3f32-0889-e063-6294a90aa707
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bromfenac
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA206911
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-02-07
Substance
BROMFENAC SODIUM
Active strength
.76 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
bromfenac
Brand name suffix
0.075%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMFENAC SODIUM.76 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ECV571Y37
Rxcui1790141

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
49708-755-41bromfenac0.075%1 in 1 CARTONSOLUTION/ DROPS12
49708-755-41bromfenac0.075%1 in 1 POUCHSOLUTION/ DROPS12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49708-755-41ML - Milliliter49708-755a7921f38-aa5c-49ad-99d5-d5c21b11ad4212024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49708-755BROMFENAC 0.075% (BROMFENAC) SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.]1Current NDC, 2 package rows20240208_7d723a00-4822-4e04-aa22-21de22009d0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790141bromfenac 0.075 % Ophthalmic SolutionPSN7d723a00-4822-4e04-aa22-21de22009d0a2
1790141bromfenac 0.75 MG/ML Ophthalmic SolutionSCD7d723a00-4822-4e04-aa22-21de22009d0a2
1790141bromfenac 0.075 % Ophthalmic SolutionSY7d723a00-4822-4e04-aa22-21de22009d0a2
1790141bromfenac 0.75 MG/ML (as bromfenac sodium 0.81 MG/ML) Ophthalmic SolutionSY7d723a00-4822-4e04-aa22-21de22009d0a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49708-755-41497080755411 POUCH in 1 CARTON (49708-755-41) / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER1 pouch2024-02-07NoNoCurrent