NDC 71776-100

Flarex

Fluorometholone Acetate

Flarex is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Eyevance Pharmaceuticals. The primary component is Fluorometholone Acetate.

Product ID71776-100_83d82d00-bc7d-db0b-e053-2991aa0a330f
NDC71776-100
Product TypeHuman Prescription Drug
Proprietary NameFlarex
Generic NameFluorometholone Acetate
Dosage FormSuspension/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2019-03-05
Marketing CategoryNDA / NDA
Application NumberNDA019079
Labeler NameEyevance Pharmaceuticals
Substance NameFLUOROMETHOLONE ACETATE
Active Ingredient Strength1 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71776-100-05

1 BOTTLE, PLASTIC in 1 CARTON (71776-100-05) > 5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2019-03-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71776-100-05 [71776010005]

Flarex SUSPENSION/ DROPS
Marketing CategoryNDA
Application NumberNDA019079
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-05

Drug Details

Active Ingredients

IngredientStrength
FLUOROMETHOLONE ACETATE1 mg/mL

OpenFDA Data

SPL SET ID:19918ea5-8568-44d6-b8ee-7b2197cee85c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1249631
  • 1249629
  • UPC Code
  • 0371776100059
  • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Flarex" or generic name "Fluorometholone Acetate"

    NDCBrand NameGeneric Name
    0065-0096Flarexfluorometholone acetate
    71776-100Flarexfluorometholone acetate

    Trademark Results [Flarex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FLAREX
    FLAREX
    74340342 1786390 Dead/Cancelled
    Environmental Science International, Incorporated
    1992-12-15
    FLAREX
    FLAREX
    73617344 1437695 Live/Registered
    ALCON LABORATORIES, INC.
    1986-08-29
    FLAREX
    FLAREX
    72313796 0897175 Dead/Expired
    AIROIL BURNER COMPANY
    1968-12-06

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