Invega Hafyera Injection, Suspension, Extended Release
NDC Package 50458-611-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Invega Hafyera (paliperidone palmitate) injection is a medication used to treat certain mental/mood disorders (such as schizophrenia, schizoaffective disorder). This formulation utilizes a injection, suspension, extended release delivery system. Marketed by Janssen Pharmaceuticals, Inc, this product is identified by NDC 50458-611 and is authorized under FDA application NDA207946.

Identification & Billing

NDC Package Code
50458-611-01
Package Description
1 SYRINGE in 1 CARTON / 3.5 mL in 1 SYRINGE
Product Code
50458-611
11-Digit Billing Format
50458061101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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]

Clinical Specifications

Proprietary Name
Invega Hafyera
Non-Proprietary Name
Paliperidone Palmitate
Substance Name
Paliperidone Palmitate
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
Intramuscular - Administration within a muscle.
Active Ingredient(s)
PALIPERIDONE PALMITATE 1092 mg/3.5mL
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
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.

Regulatory & Marketing

Labeler Name
Janssen Pharmaceuticals, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA207946
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-30-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J2427
Source: ASP
Inj, invega hafyera/trinza
HCPCS Dosage 1 MG
Units / Pkg 1092

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50458-611-01 identifies a specific commercial package of 1 syringe in 1 carton / 3.5 ml in 1 syringe of Invega Hafyera, a human prescription drug labeled by Janssen Pharmaceuticals, Inc. This injection, suspension, extended release is formulated for intramuscular use and contains paliperidone palmitate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Janssen Pharmaceuticals, Inc on August 30, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Janssen Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50458061101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
50458-611-01
11-Digit CMS (5-4-2)
50458-0611-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.