Adstiladrin Suspension
NDC Package 55566-1050-2

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

Package Information

Adstiladrin (nadofaragene firadenovec-vncg) suspension is aDSTILADRIN® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. This formulation utilizes a suspension delivery system. Marketed by Ferring Pharmaceuticals Inc., this product is identified by NDC 55566-1050 and is authorized under FDA application BLA125700.

Identification & Billing

NDC Package Code
55566-1050-2
Package Description
20 mL in 1 VIAL
Product Code
55566-1050
11-Digit Billing Format
55566105002
RxNorm Crosswalk
  • RxCUI: 2644440 - nadofaragene firadenovec-vncg 300000000000 VIRAL-PARTICLES in 20 ML Intravesical Suspension
  • RxCUI: 2644440 - nadofaragene firadenovec-vncg 15000000000 VIRAL-PARTICLES/ML Intravesical Suspension
  • RxCUI: 2644440 - nadofaragene firadenovec-vncg 300000000000 VIRAL-PARTICLES per 20 ML Intravesical Suspension
  • RxCUI: 2644445 - ADSTILADRIN 300000000000 VIRAL-PARTICLES in 20 ML Intravesical Suspension
  • RxCUI: 2644445 - nadofaragene firadenovec-vncg 15000000000 VIRAL-PARTICLES/ML Intravesical Suspension [Adstiladrin]

Clinical Specifications

Proprietary Name
Adstiladrin
Non-Proprietary Name
Nadofaragene Firadenovec-vncg
Substance Name
Nadofaragene Firadenovec
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Intravesical - Administration within the bladder.
Active Ingredient(s)
NADOFARAGENE FIRADENOVEC 300000000000 {VP}/mL
Usage Information
ADSTILADRIN® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Regulatory & Marketing

Labeler Name
Ferring Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125700
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-05-2023
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55566-1050). Click a package code to view its specific billing and regulatory data.

55566-1050-1
4 VIAL in 1 CARTON / 20 mL in 1 VIAL (55566-1050-0)

* 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 55566-1050-2 identifies a specific commercial package of 20 ml in 1 vial of Adstiladrin, a human prescription drug labeled by Ferring Pharmaceuticals Inc.. This suspension is formulated for intravesical use and contains nadofaragene firadenovec 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 September 05, 2023. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55566105002. 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)
55566-1050-2
11-Digit CMS (5-4-2)
55566-1050-02

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