Fosfomycin Tromethamine Powder
NDC Package 70700-268-99

11-digit billing NDC: 70700026899
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Fosfomycin Tromethamine (granules for oral solution) powders is fosfomycin Tromethamine is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin Tromethamine is not indicated for the treatment of pyelonephritis or perinephric abscess.If persistence or reappearance of bacteriuria occurs after treatment with Fosfomycin Tromethamine, other therapeutic agents should be selected. This formulation utilizes a powder delivery system. Marketed by Xiromed Llc, this product is identified by NDC 70700-268 and is authorized under FDA application ANDA212548.

Identification & Billing

NDC Package Code
70700-268-99
Package Description
1 POWDER in 1 PACKET
Product Code
70700-268
11-Digit Billing Format
70700026899
RxNorm Crosswalk
  • RxCUI: 808917 - fosfomycin 3 GM Granules for Oral Solution
  • RxCUI: 808917 - fosfomycin 3000 MG Granules for Oral Solution
  • RxCUI: 808917 - fosfomycin (as fosfomycin tromethamine) 3000 MG Granules for Oral Solution

Clinical Specifications

Proprietary Name
Fosfomycin Tromethamine
Non-Proprietary Name
Granules For Oral Solution
Substance Name
Fosfomycin Tromethamine
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FOSFOMYCIN TROMETHAMINE 3 g/1
Usage Information
Fosfomycin Tromethamine is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin Tromethamine is not indicated for the treatment of pyelonephritis or perinephric abscess.If persistence or reappearance of bacteriuria occurs after treatment with Fosfomycin Tromethamine, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.)

Regulatory & Marketing

Labeler Name
Xiromed Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA212548
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-06-2020
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70700-268). Click a package code to view its specific billing and regulatory data.

70700-268-94
1 DOSE PACK in 1 CARTON / 1 POWDER in 1 DOSE PACK

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70700-268-99 identifies a specific commercial package of 1 powder in 1 packet of Fosfomycin Tromethamine, a human prescription drug labeled by Xiromed Llc. This powder is formulated for oral use and contains fosfomycin tromethamine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Xiromed Llc on October 06, 2020. The current certification is valid through December 31, 2027.

How is this Xiromed Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70700026899. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
70700-268-99
11-Digit CMS (5-4-2)
70700-0268-99

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.