NDC 24208-602

Prolensa

Bromfenac Sodium

Prolensa is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Bausch & Lomb Incorporated. The primary component is Bromfenac Sodium.

Product ID24208-602_0e96d63b-fa0b-4bc4-a06f-f33d40358971
NDC24208-602
Product TypeHuman Prescription Drug
Proprietary NameProlensa
Generic NameBromfenac Sodium
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2013-04-05
Marketing CategoryNDA / NDA
Application NumberNDA203168
Labeler NameBausch & Lomb Incorporated
Substance NameBROMFENAC SODIUM
Active Ingredient Strength1 mg/mL
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 24208-602-03

1 BOTTLE, DROPPER in 1 CARTON (24208-602-03) > 3 mL in 1 BOTTLE, DROPPER
Marketing Start Date2013-04-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 24208-602-04 [24208060204]

Prolensa SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA203168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-30

NDC 24208-602-06 [24208060206]

Prolensa SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA203168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-05

NDC 24208-602-03 [24208060203]

Prolensa SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA203168
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-04-05

NDC 24208-602-01 [24208060201]

Prolensa SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA203168
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-04-05
Marketing End Date2016-03-31

NDC 24208-602-02 [24208060202]

Prolensa SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA203168
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-21
Marketing End Date2014-12-23

Drug Details

Active Ingredients

IngredientStrength
BROMFENAC SODIUM.7 mg/mL

OpenFDA Data

SPL SET ID:4e072537-f73c-4a96-a65f-e2805ce112d8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1375922
  • 1375917
  • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Cyclooxygenase Inhibitors [MoA]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    Medicade Reported Pricing

    24208060203 PROLENSA 0.07% EYE DROPS

    Pricing Unit: ML | Drug Type:

    24208060201 PROLENSA 0.07% EYE DROPS

    Pricing Unit: ML | Drug Type:

    Trademark Results [Prolensa]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROLENSA
    PROLENSA
    85336395 4407493 Live/Registered
    BAUSCH & LOMB PHARMA HOLDINGS CORP.
    2011-06-02

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