Fosfomycin Tromethamine Granule
NDC Package 68094-064-20

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Fosfomycin Tromethamine granules is a medication an antibiotic used to treat bladder infections (such as acute cystitis or lower urinary tract infections) in women. This formulation utilizes a granule delivery system. Marketed by Precision Dose, Inc., this product is identified by NDC 68094-064 and is authorized under FDA application ANDA217187.

Identification & Billing

NDC Package Code
68094-064-20
Package Description
1 PACKET in 1 CARTON / 1 GRANULE in 1 PACKET (68094-064-01)
Product Code
68094-064
11-Digit Billing Format
68094006420
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 - A small particle or grain.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FOSFOMYCIN TROMETHAMINE 3 g/1
Usage Information
This medication is an antibiotic used to treat bladder infections (such as acute cystitis or lower urinary tract infections) in women. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. Fosfomycin should not be used to treat infections outside the bladder (such as kidney infections).

Regulatory & Marketing

Labeler Name
Precision Dose, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217187
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-15-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68094-064-20 identifies a specific commercial package of 1 packet in 1 carton / 1 granule in 1 packet (68094-064-01) of Fosfomycin Tromethamine, a human prescription drug labeled by Precision Dose, Inc.. This granule 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 Precision Dose, Inc. on February 15, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is an antibiotic used to treat bladder infections (such as acute cystitis or lower urinary tract infections) in women. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. Fosfomycin should not be used to treat infections outside the bladder (such as kidney infections).

How is this Precision Dose, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68094006420. 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)
68094-064-20
11-Digit CMS (5-4-2)
68094-0064-20

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