Fosfomycin Tromethamine Granule, For Solution
NDC Package 69097-579-67

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, for solution delivery system. Marketed by Cipla Usa Inc., this product is identified by NDC 69097-579 and is authorized under FDA application ANDA211881.

Identification & Billing

NDC Package Code
69097-579-67
Package Description
1 DOSE PACK in 1 CARTON / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK
Product Code
69097-579
11-Digit Billing Format
69097057967
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
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
Cipla Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211881
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-26-2022
Listing Expiration
12-31-2026
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 69097-579-67 identifies a specific commercial package of 1 dose pack in 1 carton / 1 granule, for solution in 1 dose pack of Fosfomycin Tromethamine, a human prescription drug labeled by Cipla Usa Inc.. 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 Cipla Usa Inc. on January 26, 2022. The current certification is valid through December 31, 2026.

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 Cipla Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097057967. 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 (5-3-2)
69097-579-67
11-Digit CMS (5-4-2)
69097-0579-67

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