Paliperidone Tablet, Extended Release
NDC Package 46708-804-30

11-digit billing NDC: 46708080430
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Paliperidone tablets is paliperidone extended-release tablets are contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone extended-release tablets formulation. This formulation utilizes a tablet, extended release delivery system. Marketed by Alembic Pharmaceuticals Limited, this product is identified by NDC 46708-804 and is authorized under FDA application ANDA218330.

Identification & Billing

NDC Package Code
46708-804-30
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
46708-804
11-Digit Billing Format
46708080430
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
Non-Proprietary Name
Paliperidone
Substance Name
Paliperidone
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PALIPERIDONE 3 mg/1
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
Paliperidone extended-release tablets are contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone extended-release tablets formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone.

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA218330
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-30-2024
Listing Expiration
12-31-2027
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 46708-804-30 identifies a specific commercial package of 30 tablet, extended release in 1 bottle of Paliperidone, a human prescription drug labeled by Alembic Pharmaceuticals Limited. This tablet, extended release is formulated for oral use and contains paliperidone 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 Alembic Pharmaceuticals Limited on September 30, 2024. The current certification is valid through December 31, 2027.

How is this Alembic Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46708080430. 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)
46708-804-30
11-Digit CMS (5-4-2)
46708-0804-30

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