1. Home
  2. Labeler Index
  3. Bluebird Bio, Inc.
  4. 73554-2111
  5. NDC Package Code: 73554-2111-1 Skysona

NDC Package 73554-2111-1 Skysona

Elivaldogene Autotemcel Suspension Intravenous - 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:
73554-2111-1
Package Description:
1 SUSPENSION in 1 BAG
Product Code:
73554-2111
Proprietary Name:
Skysona
Non-Proprietary Name:
Elivaldogene Autotemcel
Substance Name:
Elivaldogene Autotemcel
Usage Information:
SKYSONA is indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD). Early, active cerebral adrenoleukodystrophy refers to asymptomatic or mildly symptomatic (neurologic function score, NFS ≤ 1) boys who have gadolinium enhancement on brain magnetic resonance imaging (MRI) and Loes scores of 0.5-9.This indication is approved under accelerated approval based on 24-month Major Functional Disability (MFD)-free survival [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
11-Digit NDC Billing Format:
73554211101
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2612552 - elivaldogene autotemcel 30,000,000 CELLS/mL in 20 ML Injection
  • RxCUI: 2612552 - 20 ML elivaldogene autotemcel 30000000 CELLS/ML Injection
  • RxCUI: 2612552 - elivaldogene autotemcel 30,000,000 CELLS/ML per 20 ML Injection
  • RxCUI: 2612558 - skysona 30,000,000 CELLS/mL in 20 ML Injection
  • RxCUI: 2612558 - 20 ML elivaldogene autotemcel 30000000 CELLS/ML Injection [Skysona]
    • Product Type:
    Cellular Therapy
    Labeler Name:
    Bluebird Bio, Inc.
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • ELIVALDOGENE AUTOTEMCEL 30000000 1/1
    • Sample Package:
    No
    FDA Application Number:
    BLA125755
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    09-16-2022
    Listing Expiration Date:
    12-31-2025
    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 73554-2111-1?

    The NDC Packaged Code 73554-2111-1 is assigned to a package of 1 suspension in 1 bag of Skysona, a cellular therapy labeled by Bluebird Bio, Inc.. The product's dosage form is suspension and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 73554-2111 included in the NDC Directory?

    Yes, Skysona with product code 73554-2111 is active and included in the NDC Directory. The product was first marketed by Bluebird Bio, Inc. on September 16, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 73554-2111-1?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 73554-2111-1?

    The 11-digit format is 73554211101. 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
    5-4-173554-2111-15-4-273554-2111-01