Drugplain

Fosfomycin Tromethamine 3 g/1

Fosfomycin Tromethamine · GRANULE, FOR SOLUTION · Ascend Laboratories, LLC

2 Recalls on Record
Plain English

Fosfomycin tromethamine is an antibiotic granule taken by mouth as a single dose to treat uncomplicated urinary tract infections. It works by killing bacteria that cause bladder infections.

Key Facts

Brand Name
Fosfomycin Tromethamine
Generic Name
Fosfomycin Tromethamine
NDC Code (Product)
67877-749
Manufacturer
Ascend Laboratories, LLC
Strength
3 g/1
Dosage Form
GRANULE, FOR SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA214554
Marketing Start
10/22/2021

Recall History

2 Recalls on Record
Class III07/18/2023

Ascend Laboratories, LLC

Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.

TerminatedVoluntary: Firm initiated
Class II01/16/2024

Ascend Laboratories, LLC

Failed Impurities/Degradation Specification: Out of specification for organic impurities

OngoingVoluntary: Firm initiated

Frequently Asked Questions

What is Fosfomycin Tromethamine used for?

Fosfomycin tromethamine is an antibiotic granule taken by mouth as a single dose to treat uncomplicated urinary tract infections. It works by killing bacteria that cause bladder infections.

Is Fosfomycin Tromethamine a controlled substance?

Fosfomycin Tromethamine is not classified as a controlled substance by the DEA.

What is the generic name for Fosfomycin Tromethamine?

The generic name for Fosfomycin Tromethamine is Fosfomycin Tromethamine. There are 2 other brand versions of Fosfomycin Tromethamine.

What is the NDC code for Fosfomycin Tromethamine 3 g/1?

The NDC (National Drug Code) for Fosfomycin Tromethamine 3 g/1 is 67877-749, listed by Ascend Laboratories, LLC.

Product NDC

67877-749

Package NDC

67877-749-57

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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