Iloperidone Tablet
NDC Package 0378-0633-91

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

Iloperidone tablets is a medication used to treat certain mental/mood disorders (such as schizophrenia). This formulation utilizes a tablet delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-0633 and is authorized under FDA application ANDA207231.

Identification & Billing

NDC Package Code
0378-0633-91
Package Description
60 TABLET in 1 BOTTLE
Product Code
0378-0633
11-Digit Billing Format
00378063391
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Iloperidone
Non-Proprietary Name
Iloperidone
Substance Name
Iloperidone
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ILOPERIDONE 6 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). Iloperidone helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there). Iloperidone is a psychiatric medication that belongs to the 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
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207231
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-20-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0378-0633). Click a package code to view its specific billing and regulatory data.

0378-0633-01
100 TABLET in 1 BOTTLE
0378-0633-88
10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK

* 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 0378-0633-91 identifies a specific commercial package of 60 tablet in 1 bottle of Iloperidone, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This tablet is formulated for oral use and contains iloperidone 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 Mylan Pharmaceuticals Inc. on March 20, 2017. 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). Iloperidone helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there). Iloperidone is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378063391. 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 (4-4-2)
0378-0633-91
11-Digit CMS (5-4-2)
00378-0633-91

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