Drugplain

Fosfomycin Tromethamine 3 g/1

Fosfomycin tromethamine · GRANULE, FOR SOLUTION · Aucta Pharmaceuticals, Inc.

2 Recalls on Record
Plain English

Fosfomycin Tromethamine is a granule, for solution containing fosfomycin tromethamine at 3 g/1, taken oral. Manufactured by Aucta Pharmaceuticals, Inc..

Key Facts

Brand Name
Fosfomycin Tromethamine
Generic Name
Fosfomycin tromethamine
NDC Code (Product)
73289-0067
Manufacturer
Aucta Pharmaceuticals, Inc.
Strength
3 g/1
Dosage Form
GRANULE, FOR SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA217772
Marketing Start
04/09/2026

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 contains Fosfomycin tromethamine. It is a granule, for solution taken oral. Consult your doctor for specific uses.

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 73289-0067, listed by Aucta Pharmaceuticals, Inc..

Product NDC

73289-0067

Package NDC

73289-0067-1

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

Data from openFDA · Public domain (CC0 1.0)