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  5. NDC Package Code: 69488-010-61 Pluvicto

NDC Package 69488-010-61 Pluvicto

Lutetium Lu 177 Vipivotide Tetraxetan Injection, Solution 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:
69488-010-61
Package Description:
1 VIAL, GLASS in 1 PACKAGE / 7.5 mL in 1 VIAL, GLASS
Product Code:
69488-010
Proprietary Name:
Pluvicto
Non-Proprietary Name:
Lutetium Lu 177 Vipivotide Tetraxetan
Substance Name:
Lutetium Lu-177 Vipivotide Tetraxetan
Usage Information:
PLUVICTO is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.
11-Digit NDC Billing Format:
69488001061
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: 2597057 - lutetium Lu 177 vipivotide tetraxetan 1000 MBq/mL Injection
  • RxCUI: 2597057 - 12.5 ML lutetium Lu 177 vipivotide tetraxetan 27 MCI/ML Injection
  • RxCUI: 2597057 - lutetium Lu 177 vipivotide tetraxetan 200 mCi per 12.5 ML Injection
  • RxCUI: 2597057 - lutetium Lu 177 vipivotide tetraxetan 7.4 GBq per 12.5 ML Injection
  • RxCUI: 2597060 - PLUVICTO 1000 MBq/mL (27 MCI/ML) Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Advanced Accelerator Applications Usa, Inc
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN 27 mCi/mL
    • Pharmacologic Class(es):
  • Radioligand Activity - [MoA] (Mechanism of Action)
  • Radioligand Therapeutic Agent - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA215833
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-23-2022
    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 69488-010-61?

    The NDC Packaged Code 69488-010-61 is assigned to a package of 1 vial, glass in 1 package / 7.5 ml in 1 vial, glass of Pluvicto, a human prescription drug labeled by Advanced Accelerator Applications Usa, Inc. The product's dosage form is injection, solution 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 69488-010 included in the NDC Directory?

    Yes, Pluvicto with product code 69488-010 is active and included in the NDC Directory. The product was first marketed by Advanced Accelerator Applications Usa, Inc on March 23, 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 69488-010-61?

    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 69488-010-61?

    The 11-digit format is 69488001061. 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
    5-3-269488-010-615-4-269488-0010-61