NDC 0456-4300

Monurol

Fosfomycin Tromethamine

Monurol is a Oral Powder in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Fosfomycin Tromethamine.

Product ID0456-4300_427e74c9-6716-451d-8aa1-ef33ebe59dab
NDC0456-4300
Product TypeHuman Prescription Drug
Proprietary NameMonurol
Generic NameFosfomycin Tromethamine
Dosage FormPowder
Route of AdministrationORAL
Marketing Start Date1996-12-19
Marketing End Date2023-11-30
Marketing CategoryNDA / NDA
Application NumberNDA050717
Labeler NameAllergan, Inc.
Substance NameFOSFOMYCIN TROMETHAMINE
Active Ingredient Strength3 g/1
NDC Exclude FlagN

Packaging

NDC 0456-4300-01

1 PACKET in 1 CARTON (0456-4300-01) > 1 POWDER in 1 PACKET (0456-4300-08)
Marketing Start Date1996-12-19
Marketing End Date2023-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0456-4300-08 [00456430008]

Monurol POWDER
Marketing CategoryNDA
Application NumberNDA050717
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-12-19

NDC 0456-4300-01 [00456430001]

Monurol POWDER
Marketing CategoryNDA
Application NumberNDA050717
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-12-19

Drug Details

Active Ingredients

IngredientStrength
FOSFOMYCIN TROMETHAMINE3 g/1

OpenFDA Data

SPL SET ID:ad155d62-9b49-4a50-a2ae-d3aad8155936
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 808921
  • 808917

    • NDC Crossover Matching brand name "Monurol" or generic name "Fosfomycin Tromethamine"

    NDCBrand NameGeneric Name
    0456-4300MonurolFosfomycin tromethamine
    50090-6130Fosfomycin TromethamineFosfomycin Tromethamine
    63629-9470Fosfomycin TromethamineFosfomycin Tromethamine
    67877-749Fosfomycin TromethamineFosfomycin Tromethamine
    69097-579FOSFOMYCIN TROMETHAMINEFOSFOMYCIN TROMETHAMINE
    82036-4274Fosfomycin TromethamineFosfomycin Tromethamine

    Trademark Results [Monurol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MONUROL
    MONUROL
    74208008 2074096 Live/Registered
    ZAMBON S.P.A.
    1991-09-30
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