FDA.reportPublic FDA data

bromfenac sodium

Product NDC
68180-433
11-digit product format
681800433
Labeler code
68180
Product ID
68180-433_bdba6fae-8155-4d11-a0ec-a68e3c934ff9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bromfenac sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA206027
Marketing category
ANDA
Marketing start
2024-01-08
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
68180-433-02bromfenac sodium3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS36
68180-433-02bromfenac sodium1 in 1 CARTONSOLUTION/ DROPS16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-433-02ML - Milliliter68180-433a3cf69a7-7694-4536-9686-92866d93dc4f12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-433BROMFENAC SODIUM SOLUTION/ DROPS [LUPIN PHARMACEUTICALS, INC.]5Current NDC, 2 package rows20250309_26f3e5b3-a739-4b09-8046-e71ecb3a5a7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1375917bromfenac 0.07 % Ophthalmic SolutionPSN26f3e5b3-a739-4b09-8046-e71ecb3a5a7b6
1375917bromfenac 0.7 MG/ML Ophthalmic SolutionSCD26f3e5b3-a739-4b09-8046-e71ecb3a5a7b6
1375917bromfenac 0.07 % Ophthalmic SolutionSY26f3e5b3-a739-4b09-8046-e71ecb3a5a7b6
1375917bromfenac 0.7 MG/ML (as bromfenac sodium 0.805 MG/ML) Ophthalmic SolutionSY26f3e5b3-a739-4b09-8046-e71ecb3a5a7b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68180-433-02681800433021 BOTTLE, DROPPER in 1 CARTON (68180-433-02) / 3 mL in 1 BOTTLE, DROPPER2024-01-08NoNoCurrent