NDC 25357-023

Photrexa

Riboflavin 5-phosphate Ophthalmic

Photrexa is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Glaukos Corporation. The primary component is Riboflavin 5'-phosphate Sodium Anhydrous.

Product ID25357-023_030af81d-5c28-44e7-8386-6c5b3f569af0
NDC25357-023
Product TypeHuman Prescription Drug
Proprietary NamePhotrexa
Generic NameRiboflavin 5-phosphate Ophthalmic
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2016-04-15
Marketing CategoryNDA / NDA
Application NumberNDA203324
Labeler NameGlaukos Corporation
Substance NameRIBOFLAVIN 5'-PHOSPHATE SODIUM ANHYDROUS
Active Ingredient Strength1 mg/mL
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 25357-023-01

10 POUCH in 1 BOX (25357-023-01) > 1 POUCH in 1 POUCH > 1 SYRINGE, GLASS in 1 POUCH > 3 mL in 1 SYRINGE, GLASS
Marketing Start Date2016-04-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25357-023-01 [25357002301]

Photrexa SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA203324
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-04-15

Drug Details

Active Ingredients

IngredientStrength
RIBOFLAVIN 5'-PHOSPHATE SODIUM1.46 mg/mL

OpenFDA Data

SPL SET ID:f82cfe92-1a24-11e3-8ffd-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1925830
  • 1925825
  • NDC Crossover Matching brand name "Photrexa" or generic name "Riboflavin 5-phosphate Ophthalmic"

    NDCBrand NameGeneric Name
    25357-023Photrexariboflavin 5-phosphate ophthalmic
    25357-025Photrexa Cross-linking Kitriboflavin 5-phosphate ophthalmic

    Trademark Results [Photrexa]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PHOTREXA
    PHOTREXA
    85849014 4724270 Live/Registered
    Avedro Inc.
    2013-02-13

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