Rebyota Suspension
NDC Package 55566-9800-2

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

Package Information

Rebyota (donor human stool) suspension is rEBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI. This formulation utilizes a suspension delivery system. Marketed by Ferring Pharmaceuticals Inc., this product is identified by NDC 55566-9800 and is authorized under FDA application BLA125739.

Identification & Billing

NDC Package Code
55566-9800-2
Package Description
1 CARTON in 1 CARTON / 1 BAG in 1 CARTON (55566-9800-1) / 150 mL in 1 BAG (55566-9800-0)
Product Code
55566-9800
11-Digit Billing Format
55566980002
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rebyota
Non-Proprietary Name
Donor Human Stool
Substance Name
Donor Human Stool
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
DONOR HUMAN STOOL 50000000000 [CFU]/150mL
Usage Information
REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI.

Regulatory & Marketing

Labeler Name
Ferring Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125739
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-09-2023
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 55566-9800-2 identifies a specific commercial package of 1 carton in 1 carton / 1 bag in 1 carton (55566-9800-1) / 150 ml in 1 bag (55566-9800-0) of Rebyota, a human prescription drug labeled by Ferring Pharmaceuticals Inc.. This suspension is formulated for rectal use and contains donor human stool 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 Ferring Pharmaceuticals Inc. on January 09, 2023. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55566980002. 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 (5-4-1)
55566-9800-2
11-Digit CMS (5-4-2)
55566-9800-02

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