Prolensa

Product NDC
24208-602
11-digit product format
242080602
Labeler code
24208
Product ID
24208-602_5114fa15-9db8-23b9-e063-6294a90ad057
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bromfenac Sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA203168
Marketing category
NDA
Marketing start
2013-04-05
Substance
BROMFENAC SODIUM
Active strength
.7 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
Prolensa
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMFENAC SODIUM.7 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ECV571Y37
Rxcui1375917, 1375922

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
24208-602-01Prolensa1.6 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1.619
24208-602-01Prolensa1 in 1 CARTONSOLUTION/ DROPS119
24208-602-03Prolensa3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS319
24208-602-03Prolensa1 in 1 CARTONSOLUTION/ DROPS119
24208-602-04Prolensa1 in 1 CARTONSOLUTION/ DROPS119
24208-602-04Prolensa3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS319
24208-602-06Prolensa1 in 1 CARTONSOLUTION/ DROPS119
24208-602-06Prolensa0.6 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS0.619

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-602-01ML - Milliliter24208-6023683772a-db3f-4178-84ca-d664b5a6364012013-05-02
24208-602-03ML - Milliliter24208-6027da1f353-3779-4a4b-9750-afafce6cd5c512013-05-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-602PROLENSA (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]17Current NDC, Legacy NDC, 8 package rows20250302_4e072537-f73c-4a96-a65f-e2805ce112d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1375917bromfenac 0.07 % Ophthalmic SolutionPSN4e072537-f73c-4a96-a65f-e2805ce112d819
1375922PROLENSA 0.07 % Ophthalmic SolutionPSN4e072537-f73c-4a96-a65f-e2805ce112d819
1375922bromfenac 0.7 MG/ML Ophthalmic Solution [Prolensa]SBD4e072537-f73c-4a96-a65f-e2805ce112d819
1375917bromfenac 0.7 MG/ML Ophthalmic SolutionSCD4e072537-f73c-4a96-a65f-e2805ce112d819
1375917bromfenac 0.07 % Ophthalmic SolutionSY4e072537-f73c-4a96-a65f-e2805ce112d819
1375917bromfenac 0.7 MG/ML (as bromfenac sodium 0.805 MG/ML) Ophthalmic SolutionSY4e072537-f73c-4a96-a65f-e2805ce112d819
1375922Prolensa (bromfenac 0.07 % (as bromfenac sodium 0.0805 % )) Ophthalmic SolutionSY4e072537-f73c-4a96-a65f-e2805ce112d819
1375922Prolensa 0.7 MG/ML Ophthalmic SolutionSY4e072537-f73c-4a96-a65f-e2805ce112d819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-602-01242080602011.6 mL in 1 BOTTLE, DROPPER1.6 mlHistorical
24208-602-03242080602031 BOTTLE, DROPPER in 1 CARTON (24208-602-03) / 3 mL in 1 BOTTLE, DROPPER2013-04-050000-00-00NoNoCurrent
24208-602-04242080602041 BOTTLE, DROPPER in 1 CARTON (24208-602-04) / 3 mL in 1 BOTTLE, DROPPER2013-04-050000-00-00NoNoCurrent
24208-602-06242080602061 BOTTLE, DROPPER in 1 CARTON (24208-602-06) / .6 mL in 1 BOTTLE, DROPPER2013-04-050000-00-00YesNoCurrent