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NDC 43068-906 Fanapt

Iloperidone Kit Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 43068-906?
  4. Fanapt Uses
  5. NDC to RxNorm Crosswalk

Product Information

Get all the details for National Drug Code (NDC) 43068-906 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
43068-906
Proprietary Name:
Fanapt
Non-Proprietary Name: [1]
Iloperidone
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler Name: [5]
Vanda Pharmaceuticals Inc.
Labeler Code:
43068
Product Label ID:
33f60b40-3fca-11de-8f56-0002a5d5c51b
FDA Application Number: [6]
NDA022192
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
05-01-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
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Product Details

What is NDC 43068-906?

The NDC code 43068-906 is assigned by the FDA to the product Fanapt which is a human prescription drug product labeled by Vanda Pharmaceuticals Inc.. The generic name of Fanapt is iloperidone. The product's dosage form is kit and is administered via oral form. The product is distributed in a single package with assigned NDC code 43068-906-08 1 blister pack in 1 dose pack / 1 kit in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Fanapt?

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.

What is the NDC to RxNorm Crosswalk for Fanapt?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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: 848722 - iloperidone 1 MG Oral Tablet

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".