NDC Package 50419-208-01 Xofigo

Radium Ra 223 Dichloride Injection Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
50419-208-01
Package Description:
6 mL in 1 VIAL, SINGLE-DOSE
Product Code:
Proprietary Name:
Xofigo
Non-Proprietary Name:
Radium Ra 223 Dichloride
Substance Name:
Radium Ra-223 Dichloride
Usage Information:
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
11-Digit NDC Billing Format:
50419020801
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: 1424214 - radium Ra-223 1100 kBq/ML in 6 ML Injection
  • RxCUI: 1424214 - 6 ML radium chloride Ra-223 30 MCI/ML Injection
  • RxCUI: 1424214 - radium Ra-223 dichloride 178 MCI per 6 ML Injection
  • RxCUI: 1424214 - radium Ra-223 dichloride 6600 kBq per 6 ML Injection
  • RxCUI: 1424219 - Xofigo 1100 kBq/ML in 6 ML Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bayer Healthcare Pharmaceuticals Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Sample Package:
    No
    FDA Application Number:
    NDA203971
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-20-2013
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 50419-208-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    50419020801A9606Radium Ra223 dichloride ther1 mCi6111

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50419-208-01?

    The NDC Packaged Code 50419-208-01 is assigned to a package of 6 ml in 1 vial, single-dose of Xofigo, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. The product's dosage form is injection 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 50419-208 included in the NDC Directory?

    Yes, Xofigo with product code 50419-208 is active and included in the NDC Directory. The product was first marketed by Bayer Healthcare Pharmaceuticals Inc. on May 20, 2013 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 50419-208-01?

    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 50419-208-01?

    The 11-digit format is 50419020801. 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 5-3-2 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
    5-3-250419-208-015-4-250419-0208-01