Paliperidone Tablet, Extended Release
NDC Package 43975-352-03

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

Package Information

Paliperidone tablets is a medication used to treat certain mental/mood disorders (such as schizophrenia, schizoaffective disorder). This formulation utilizes a tablet, extended release delivery system. Marketed by Ani Pharmaceuticals, Inc., this product is identified by NDC 43975-352 and is authorized under FDA application ANDA204452.

Identification & Billing

NDC Package Code
43975-352-03
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
43975-352
11-Digit Billing Format
43975035203
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
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 9 mg/1
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). 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. Paliperidone belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

Regulatory & Marketing

Labeler Name
Ani Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204452
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-27-2019
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 43975-352-03 identifies a specific commercial package of 30 tablet, extended release in 1 bottle of Paliperidone, a human prescription drug labeled by Ani Pharmaceuticals, Inc.. 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 Ani Pharmaceuticals, Inc. on November 27, 2019. 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). 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. Paliperidone belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43975035203. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
43975-352-03
11-Digit CMS (5-4-2)
43975-0352-03

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