Fanapt Kit
NDC Package 43068-113-04

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

Package Information

Fanapt (iloperidone) kits is a medication used to treat certain mental/mood disorders (such as schizophrenia). This formulation utilizes a kit delivery system. Marketed by Vanda Pharmaceuticals Inc., this product is identified by NDC 43068-113 and is authorized under FDA application NDA022192.

Identification & Billing

NDC Package Code
43068-113-04
Package Description
1 BLISTER PACK in 1 DOSE PACK / 1 KIT in 1 BLISTER PACK
Product Code
43068-113
11-Digit Billing Format
43068011304
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 2714234 - {4 (iloperidone 1 MG Oral Tablet) / 2 (iloperidone 2 MG Oral Tablet) / 2 (iloperidone 6 MG Oral Tablet) } Pack
  • RxCUI: 2714234 - iloperidone 1 MG Oral Tablet (4) / iloperidone 2 MG Oral Tablet (2) / iloperidone 6 MG Oral Tablet (2) Titration Pack C
  • RxCUI: 2714235 - {4 (iloperidone 1 MG Oral Tablet [Fanapt]) / 2 (iloperidone 2 MG Oral Tablet [Fanapt]) / 2 (iloperidone 6 MG Oral Tablet [Fanapt]) } Pack [Fanapt Titration Pack C]
  • RxCUI: 2714235 - Fanapt Titration Pack C
  • RxCUI: 2720356 - {6 (iloperidone 1 MG Oral Tablet) / 2 (iloperidone 2 MG Oral Tablet) / 2 (iloperidone 6 MG Oral Tablet) / 2 (iloperidone 8 MG Oral Tablet) } Pack

Clinical Specifications

Proprietary Name
Fanapt
Non-Proprietary Name
Iloperidone
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Oral - Administration to or by way of the mouth.
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
Vanda Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022192
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-01-2015
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 43068-113-04 identifies a specific commercial package of 1 blister pack in 1 dose pack / 1 kit in 1 blister pack of Fanapt, a human prescription drug labeled by Vanda Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This kit is formulated for oral use and contains 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 Vanda Pharmaceuticals Inc. on December 01, 2015. 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). 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 Vanda Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43068011304. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
43068-113-04
11-Digit CMS (5-4-2)
43068-0113-04

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