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  5. NDC Package Code: 50458-560-01 Invega Sustenna

NDC Package 50458-560-01 Invega Sustenna

Paliperidone Palmitate Injection Intramuscular - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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:
50458-560-01
Package Description:
1 SYRINGE in 1 KIT / .25 mL in 1 SYRINGE
Product Code:
50458-560
Proprietary Name:
Invega Sustenna
Non-Proprietary Name:
Paliperidone Palmitate
Substance Name:
Paliperidone Palmitate
Usage Information:
This medication is used to treat certain mental/mood disorders (such as schizophrenia, schizoaffective disorder). Paliperidone is an antipsychotic drug (atypical type). It works by helping to restore the balance of certain natural chemicals (neurotransmitters) in the brain. This medication can decrease hallucinations and help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life.
11-Digit NDC Billing Format:
50458056001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 858048 - paliperidone palmitate 78 in 0.5 ML Prefilled Syringe
  • RxCUI: 858048 - 0.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe
  • RxCUI: 858048 - paliperidone palmitate 78 MG per 0.5 ML Prefilled Syringe
  • RxCUI: 858051 - Invega Sustenna 78 MG in 0.5 mL Prefilled Syringe
  • RxCUI: 858051 - 0.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Invega]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen 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):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • PALIPERIDONE PALMITATE 39 mg/.25mL
    • Pharmacologic Class(es):
  • Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA022264
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-31-2009
    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 50458-560-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    50458056001J2426Inj, invega sustenna, 1 mg1 MG0.2513939

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50458-560-01?

    The NDC Packaged Code 50458-560-01 is assigned to a package of 1 syringe in 1 kit / .25 ml in 1 syringe of Invega Sustenna, a human prescription drug labeled by Janssen Pharmaceuticals, Inc.. The product's dosage form is injection and is administered via intramuscular form.

    Is NDC 50458-560 included in the NDC Directory?

    Yes, Invega Sustenna with product code 50458-560 is active and included in the NDC Directory. The product was first marketed by Janssen Pharmaceuticals, Inc. on July 31, 2009 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 50458-560-01?

    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 50458-560-01?

    The 11-digit format is 50458056001. 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
    5-3-250458-560-015-4-250458-0560-01