Invega Trinza Injection, Suspension, Extended Release
NDC Package 50458-607-01

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

Package Information

Invega Trinza (paliperidone palmitate) injection is paliperidone is used to treat a certain mental/mood disorder called schizophrenia. This formulation utilizes a injection, suspension, extended release delivery system. Marketed by Janssen Pharmaceuticals, Inc, this product is identified by NDC 50458-607 and is authorized under FDA application NDA207946.

Identification & Billing

NDC Package Code
50458-607-01
Package Description
1 SYRINGE in 1 KIT / 1 mL in 1 SYRINGE
Product Code
50458-607
11-Digit Billing Format
50458060701
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1650966 - paliperidone palmitate 273 MG in 0.88 ML Prefilled Syringe
  • RxCUI: 1650966 - 0.88 ML paliperidone palmitate 310 MG/ML Prefilled Syringe
  • RxCUI: 1650966 - paliperidone palmitate 273 MG per 0.88 ML Prefilled Syringe
  • RxCUI: 1650968 - Invega Trinza 273 MG in 0.88 ML Prefilled Syringe
  • RxCUI: 1650968 - 0.88 ML paliperidone palmitate 310 MG/ML Prefilled Syringe [Invega]

Clinical Specifications

Proprietary Name
Invega Trinza
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 410 mg/1.32mL
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
Paliperidone is used to treat a certain mental/mood disorder called schizophrenia. This medication can decrease hallucinations, help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life. Paliperidone is an antipsychotic drug (atypical type). It works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain. This long-acting form of paliperidone is used only after you have received treatment with the form that is injected once a month for at least 4 months.

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
05-19-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50458-607-01 identifies a specific commercial package of 1 syringe in 1 kit / 1 ml in 1 syringe of Invega Trinza, 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 May 19, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Paliperidone is used to treat a certain mental/mood disorder called schizophrenia. This medication can decrease hallucinations, help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life. Paliperidone is an antipsychotic drug (atypical type). It works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain. This long-acting form of paliperidone is used only after you have received treatment with the form that is injected once a month for at least 4 months.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50458060701. 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)
50458-607-01
11-Digit CMS (5-4-2)
50458-0607-01

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