Paliperidone
NDC Package 49252-034-10

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Paliperidone is extended-release tablets are indicated for the treatment of schizophrenia [see Clinical Studies (14.1)]. Marketed by Inventia Healthcare Limited, this product is identified by NDC 49252-034 and is authorized under FDA application ANDA204452.

Identification & Billing

NDC Package Code
49252-034-10
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
49252-034
11-Digit Billing Format
49252003410
RxNorm Crosswalk
  • RxCUI: 672567 - paliperidone 3 MG 24HR Extended Release Oral Tablet
  • RxCUI: 672567 - 24 HR paliperidone 3 MG Extended Release Oral Tablet
  • RxCUI: 672567 - paliperidone 3 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 672569 - paliperidone 6 MG 24HR Extended Release Oral Tablet
  • RxCUI: 672569 - 24 HR paliperidone 6 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Paliperidone
Dosage Form
-
Usage Information
Paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see Clinical Studies (14.1)]. The efficacy of paliperidone in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.

Regulatory & Marketing

Labeler Name
Inventia Healthcare Limited
FDA Application #
ANDA204452
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2019
Listing Expiration
12-31-2020
Exclude Flag
I
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 49252-034-10 identifies a specific commercial package of 30 tablet, extended release in 1 bottle of Paliperidone, labeled by Inventia Healthcare Limited. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Inventia Healthcare Limited on September 01, 2019. The current certification is valid through December 31, 2020.

How is this Inventia Healthcare Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49252003410. 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)
49252-034-10
11-Digit CMS (5-4-2)
49252-0034-10

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