Exem Foam Kit
NDC Package 73254-310-01

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

Package Information

Exem Foam (air polymer-type a intrauterine foam) kits is exEm ® Foam is indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility. This formulation utilizes a kit delivery system. Marketed by Giskit Pharma B.v., this product is identified by NDC 73254-310 and is authorized under FDA application NDA212279.

Identification & Billing

NDC Package Code
73254-310-01
Package Description
1 KIT in 1 CARTON * 5 mL in 1 SYRINGE, PLASTIC * 5 mL in 1 SYRINGE, PLASTIC
Product Code
73254-310
11-Digit Billing Format
73254031001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Exem Foam
Non-Proprietary Name
Air Polymer-type A Intrauterine Foam
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Intrauterine - Administration within the uterus.
Usage Information
ExEm ® Foam is indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility.

Regulatory & Marketing

Labeler Name
Giskit Pharma B.v.
Product Type
Human Prescription Drug
FDA Application #
NDA212279
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-16-2020
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 73254-310-01 identifies a specific commercial package of 1 kit in 1 carton * 5 ml in 1 syringe, plastic * 5 ml in 1 syringe, plastic of Exem Foam, a human prescription drug labeled by Giskit Pharma B.v.. This kit is formulated for intrauterine use and contains 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 Giskit Pharma B.v. on October 16, 2020. The current certification is valid through December 31, 2026.

How is this Giskit Pharma B.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73254031001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
73254-310-01
11-Digit CMS (5-4-2)
73254-0310-01

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