NDC Package 82036-4274-8 Fosfomycin Tromethamine

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

82036-4274-8

Package Description:

1 POWDER in 1 PACKET

Product Code:

82036-4274

Proprietary Name:

Fosfomycin Tromethamine

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.)

11-Digit NDC Billing Format:

82036427408

NDC to 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

Labeler Name:

Zambon Usa, Ltd

Sample Package:

FDA Application Number:

NDA050717

Marketing Category:

NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.

Start Marketing Date:

08-25-2021

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

82036 - Zambon Usa, Ltd
- 82036-4274 - Fosfomycin Tromethamine
  - 82036-4274-8 - 1 POWDER in 1 PACKET

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
82036-4274-1	1 DOSE PACK in 1 CARTON / 1 POWDER in 1 DOSE PACK

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 82036-4274-8?

The NDC Packaged Code 82036-4274-8 is assigned to a package of 1 powder in 1 packet of Fosfomycin Tromethamine, labeled by Zambon Usa, Ltd. The product's dosage form is and is administered via form.

Is NDC 82036-4274 included in the NDC Directory?

No, Fosfomycin Tromethamine with product code 82036-4274 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Zambon Usa, Ltd on August 25, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 82036-4274-8?

The 11-digit format is 82036427408. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	82036-4274-8	5-4-2	82036-4274-08

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