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  5. NDC Package Code: 55566-9800-2 Rebyota

NDC Package 55566-9800-2 Rebyota

Donor Human Stool Suspension Rectal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
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
Proprietary Name:
Rebyota
Non-Proprietary Name:
Donor Human Stool
Substance Name:
Donor Human Stool
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.
11-Digit NDC Billing Format:
55566980002
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2626732 - fecal microbiota, live-jslm 150 ML Enema
  • RxCUI: 2626732 - fecal microbiota, live-jslm 50000000000 UNT/ML Enema
  • RxCUI: 2626732 - fecal microbiota, live-jslm 50,000,000,000 UNT/ML per 150 ML Enema
  • RxCUI: 2626737 - REBYOTA 150 ML Enema
  • RxCUI: 2626737 - fecal microbiota, live-jslm 50000000000 UNT/ML Enema [Rebyota]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Ferring Pharmaceuticals Inc.
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Rectal - Administration to the rectum.
    • Active Ingredient(s):
  • DONOR HUMAN STOOL 50000000000 [CFU]/150mL
    • Sample Package:
    No
    FDA Application Number:
    BLA125739
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    01-09-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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.

    Frequently Asked Questions

    What is NDC 55566-9800-2?

    The NDC Packaged Code 55566-9800-2 is assigned to a 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.. The product's dosage form is suspension and is administered via rectal form.

    Is NDC 55566-9800 included in the NDC Directory?

    Yes, Rebyota with product code 55566-9800 is active and included in the NDC Directory. The product was first marketed by Ferring Pharmaceuticals Inc. on January 09, 2023 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 NDC billing unit for package 55566-9800-2?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 55566-9800-2?

    The 11-digit format is 55566980002. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-155566-9800-25-4-255566-9800-02