FDA.reportPublic FDA data

bromfenac ophthalmic solution

Product NDC
82260-602
11-digit product format
822600602
Labeler code
82260
Product ID
82260-602_5114ef85-6052-bb94-e063-6294a90a1abc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bromfenac Sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Americas Inc.
Application
NDA203168
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-01-08
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
bromfenac ophthalmic solution
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMFENAC SODIUM.7 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
82260-602-03bromfenac ophthalmic solution3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS36
82260-602-03bromfenac ophthalmic solution1 in 1 CARTONSOLUTION/ DROPS16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82260-602-03ML - Milliliter82260-60251c352df-f5c6-4632-940a-3fef66bdce1212024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82260-602BROMFENAC OPHTHALMIC SOLUTION (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB AMERICAS INC.]3Current NDC, 2 package rows20240822_246e2110-6a2d-4e22-8e37-72d80796b9af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1375917bromfenac 0.07 % Ophthalmic SolutionPSN246e2110-6a2d-4e22-8e37-72d80796b9af6
1375917bromfenac 0.7 MG/ML Ophthalmic SolutionSCD246e2110-6a2d-4e22-8e37-72d80796b9af6
1375917bromfenac 0.07 % Ophthalmic SolutionSY246e2110-6a2d-4e22-8e37-72d80796b9af6
1375917bromfenac 0.7 MG/ML (as bromfenac sodium 0.805 MG/ML) Ophthalmic SolutionSY246e2110-6a2d-4e22-8e37-72d80796b9af6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82260-602-03822600602031 BOTTLE, DROPPER in 1 CARTON (82260-602-03) / 3 mL in 1 BOTTLE, DROPPER2024-01-08NoNoCurrent