Fosfomycin Tromethamine Granule, For Solution
NDC Package 73289-0067-1

11-digit billing NDC: 73289006701 · Billing unit: EA · 1 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Fosfomycin Tromethamine granules is for oral solution 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 granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. This formulation utilizes a granule, for solution delivery system. Marketed by Aucta Pharmaceuticals, Inc., this product is identified by NDC 73289-0067 and is authorized under FDA application ANDA217772.

Identification & Billing

NDC Package Code
73289-0067-1
Package Description
1 GRANULE, FOR SOLUTION in 1 PACKET
Product Code
73289-0067
11-Digit Billing Format
73289006701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
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
Fosfomycin Tromethamine
Substance Name
Fosfomycin Tromethamine
Dosage Form
Granule, For Solution - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FOSFOMYCIN TROMETHAMINE 3 g/1
Usage Information
Fosfomycin tromethamine granules for oral solution 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 granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONSand  CLINICAL STUDIESsections.)

Regulatory & Marketing

Labeler Name
Aucta Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217772
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-09-2026
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 (73289-0067). Click a package code to view its specific billing and regulatory data.

73289-0067-2
1 DOSE PACK in 1 CARTON / 1 GRANULE, FOR SOLUTION 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 73289-0067-1 identifies a specific commercial package of 1 granule, for solution in 1 packet of Fosfomycin Tromethamine, a human prescription drug labeled by Aucta Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This granule, for solution 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 Aucta Pharmaceuticals, Inc. on April 09, 2026. The current certification is valid through December 31, 2027.

How is this Aucta Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73289006701. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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 (5-4-1)
73289-0067-1
11-Digit CMS (5-4-2)
73289-0067-01

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