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  5. NDC Package Code: 50458-612-01 Invega Hafyera

NDC Package 50458-612-01 Invega Hafyera

Paliperidone Palmitate Injection, Suspension, Extended Release 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:
50458-612-01
Package Description:
1 SYRINGE in 1 CARTON / 5 mL in 1 SYRINGE
Product Code:
50458-612
Proprietary Name:
Invega Hafyera
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:
50458061201
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2570418 - paliperidone palmitate 1092 in 3.5 ML Prefilled Syringe
  • RxCUI: 2570418 - 3.5 ML paliperidone palmitate 312 MG/ML Prefilled Syringe
  • RxCUI: 2570418 - paliperidone palmitate 1092 per 3.5 ML Prefilled Syringe
  • RxCUI: 2570419 - Invega Hayfera 1092 MG in 3.5 ML Prefilled Syringe
  • RxCUI: 2570419 - 3.5 ML paliperidone palmitate 312 MG/ML Prefilled Syringe [Invega]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen Pharmaceuticals, Inc
    Dosage Form:
    Injection, Suspension, Extended Release - A sterile preparation intended for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form).
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • PALIPERIDONE PALMITATE 1560 mg/5mL
    • Pharmacologic Class(es):
  • Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA207946
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-30-2021
    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 50458-612-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    50458061201J2427Inj, invega hafyera/trinza1 MG5115601560

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50458-612-01?

    The NDC Packaged Code 50458-612-01 is assigned to a package of 1 syringe in 1 carton / 5 ml in 1 syringe of Invega Hafyera, a human prescription drug labeled by Janssen Pharmaceuticals, Inc. The product's dosage form is injection, suspension, extended release and is administered via intramuscular form.

    Is NDC 50458-612 included in the NDC Directory?

    Yes, Invega Hafyera with product code 50458-612 is active and included in the NDC Directory. The product was first marketed by Janssen Pharmaceuticals, Inc on August 30, 2021 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 50458-612-01?

    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 50458-612-01?

    The 11-digit format is 50458061201. 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
    5-3-250458-612-015-4-250458-0612-01