NDC 50436-6301

Bromday

Bromfenac

Bromday is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Unit Dose Services. The primary component is Bromfenac Sodium.

Product ID50436-6301_323f622f-6ffb-4557-af9d-4ef6f40541e8
NDC50436-6301
Product TypeHuman Prescription Drug
Proprietary NameBromday
Generic NameBromfenac
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2010-09-20
Marketing CategoryNDA / NDA
Application NumberNDA021664
Labeler NameUnit Dose Services
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 Through2019-12-31

Packaging

NDC 50436-6301-0

1.7 mL in 1 BOTTLE, DROPPER (50436-6301-0)
Marketing Start Date2010-09-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50436-6301-0 [50436630100]

Bromday SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA021664
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-09-20
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BROMFENAC SODIUM.9 mg/mL

OpenFDA Data

SPL SET ID:234a2447-90a7-4b8a-a344-7eef1e5daa6a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 578018
  • 1020510
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Bromday" or generic name "Bromfenac"

    NDCBrand NameGeneric Name
    50436-6301Bromdaybromfenac
    50383-249bromfenacbromfenac
    65862-789BromfenacBromfenac
    68083-313BROMFENACBromfenac
    72266-142BROMFENACBromfenac
    49708-754BromSitebromfenac

    Trademark Results [Bromday]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BROMDAY
    BROMDAY
    85100229 4057263 Dead/Cancelled
    ISTA Pharmaceuticals, Inc.
    2010-08-04

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