FDA.reportPublic FDA data

Bromfenac Ophthalmic Solution, 0.07%

Product NDC
60505-1006
11-digit product format
605051006
Labeler code
60505
Product ID
60505-1006_f729e800-0b53-25a7-f7dc-bee3bdf29882
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bromfenac Sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Apotex Corp.
Application
ANDA207334
Marketing category
ANDA
Marketing start
2024-07-11
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bromfenac Ophthalmic Solution, 0.07%
Listing expiration
2026-12-31

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
60505-1006-1Bromfenac Ophthalmic Solution, 0.07%1 in 1 CARTONSOLUTION/ DROPS14
60505-1006-1Bromfenac Ophthalmic Solution, 0.07%1.6 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1.64
60505-1006-2Bromfenac Ophthalmic Solution, 0.07%1 in 1 CARTONSOLUTION/ DROPS14
60505-1006-2Bromfenac Ophthalmic Solution, 0.07%3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-1006-2ML - Milliliter60505-10065bec3932-2384-4697-bc4e-61868c7f717212024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-1006BROMFENAC OPHTHALMIC SOLUTION, 0.07% (BROMFENAC SODIUM) SOLUTION/ DROPS [APOTEX CORP.]4Current NDC, 4 package rows20250323_4246c669-3c2a-2a2b-3b1c-696deb4ab519.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1375917bromfenac 0.07 % Ophthalmic SolutionPSN4246c669-3c2a-2a2b-3b1c-696deb4ab5194
1375917bromfenac 0.7 MG/ML Ophthalmic SolutionSCD4246c669-3c2a-2a2b-3b1c-696deb4ab5194
1375917bromfenac 0.07 % Ophthalmic SolutionSY4246c669-3c2a-2a2b-3b1c-696deb4ab5194
1375917bromfenac 0.7 MG/ML (as bromfenac sodium 0.805 MG/ML) Ophthalmic SolutionSY4246c669-3c2a-2a2b-3b1c-696deb4ab5194

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-1006-1605051006011 BOTTLE, DROPPER in 1 CARTON (60505-1006-1) / 1.6 mL in 1 BOTTLE, DROPPER2024-07-11NoNoHistorical
60505-1006-2605051006021 BOTTLE, DROPPER in 1 CARTON (60505-1006-2) / 3 mL in 1 BOTTLE, DROPPER2024-07-11NoNoHistorical