Hetlioz Capsule
NDC Package 43068-220-01

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

Package Information

Hetlioz (tasimelteon) capsules is tasimelteon is used to treat a certain sleep disorder (non-24-hour sleep-wake disorder). This formulation utilizes a capsule delivery system. Marketed by Vanda Pharmaceuticals Inc., this product is identified by NDC 43068-220 and is authorized under FDA application NDA205677.

Identification & Billing

NDC Package Code
43068-220-01
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
43068-220
11-Digit Billing Format
43068022001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hetlioz
Non-Proprietary Name
Tasimelteon
Substance Name
Tasimelteon
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TASIMELTEON 20 mg/1
Pharmacologic Class
Usage Information
Tasimelteon is used to treat a certain sleep disorder (non-24-hour sleep-wake disorder). It works like a natural substance called melatonin that your body produces. It helps to control your sleep-wake cycle (circadian rhythm). Tasimelteon may improve your ability to sleep at night and to be more active during the day.

Regulatory & Marketing

Labeler Name
Vanda Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA205677
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-04-2014
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 43068-220-01 identifies a specific commercial package of 30 capsule in 1 bottle of Hetlioz, a human prescription drug labeled by Vanda Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This capsule is formulated for oral use and contains tasimelteon 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 April 04, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tasimelteon is used to treat a certain sleep disorder (non-24-hour sleep-wake disorder). It works like a natural substance called melatonin that your body produces. It helps to control your sleep-wake cycle (circadian rhythm). Tasimelteon may improve your ability to sleep at night and to be more active during the day.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43068022001. 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)
43068-220-01
11-Digit CMS (5-4-2)
43068-0220-01

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