Erzofri Extended-release Injection
NDC Package 72526-110-21

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

Package Information

Erzofri Extended-release (paliperidone palmitate) injection is a medication used to treat certain mental/mood disorders (such as schizophrenia, schizoaffective disorder). This formulation utilizes a injection delivery system. Marketed by Shandong Luye Pharmaceutical Co., Ltd., this product is identified by NDC 72526-110 and is authorized under FDA application NDA216352.

Identification & Billing

NDC Package Code
72526-110-21
Package Description
1 SYRINGE, GLASS in 1 KIT / 2.25 mL in 1 SYRINGE, GLASS
Product Code
72526-110
11-Digit Billing Format
72526011021
RxNorm Crosswalk
  • RxCUI: 2699342 - paliperidone palmitate 351 MG in 2.25 ML Prefilled Syringe
  • RxCUI: 2699342 - 2.25 ML paliperidone palmitate 156 MG/ML Prefilled Syringe
  • RxCUI: 2699342 - paliperidone palmitate 351 MG per 2.25 ML Extended Release Injectable Suspension in a Prefilled Syringe
  • RxCUI: 2699342 - paliperidone palmitate 351 MG per 2.25 ML Prefilled Syringe
  • RxCUI: 2699348 - Erzofri 351 MG in 2.25 ML Prefilled Syringe

Clinical Specifications

Proprietary Name
Erzofri Extended-release
Non-Proprietary Name
Paliperidone Palmitate
Substance Name
Paliperidone Palmitate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
PALIPERIDONE PALMITATE 351 mg/2.25mL
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
Shandong Luye Pharmaceutical Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
NDA216352
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-10-2024
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72526-110). Click a package code to view its specific billing and regulatory data.

72526-110-11
1 SYRINGE, GLASS in 1 KIT / 2.25 mL in 1 SYRINGE, GLASS

* 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 72526-110-21 identifies a specific commercial package of 1 syringe, glass in 1 kit / 2.25 ml in 1 syringe, glass of Erzofri Extended-release, a human prescription drug labeled by Shandong Luye Pharmaceutical Co., Ltd.. This injection 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 Shandong Luye Pharmaceutical Co., Ltd. on December 10, 2024. The current certification is valid through December 31, 2027.

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 Shandong Luye Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72526011021. 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)
72526-110-21
11-Digit CMS (5-4-2)
72526-0110-21

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