Tasimelteon Capsule, Gelatin Coated
NDC Package 0480-4490-00

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

Tasimelteon capsules is tasimelteon is used to treat a certain sleep disorder (non-24-hour sleep-wake disorder). This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Teva Pharmaceuticals, Inc., this product is identified by NDC 0480-4490 and is authorized under FDA application ANDA211601.

Identification & Billing

NDC Package Code
0480-4490-00
Package Description
19950 CAPSULE, GELATIN COATED in 1 BOX
Product Code
0480-4490
11-Digit Billing Format
00480449000
RxNorm Crosswalk
RxCUI: 1490473 - tasimelteon 20 MG Oral Capsule

Clinical Specifications

Proprietary Name
Tasimelteon
Non-Proprietary Name
Tasimelteon
Substance Name
Tasimelteon
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
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
Teva Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211601
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-29-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
N/A

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 (0480-4490). Click a package code to view its specific billing and regulatory data.

0480-4490-56
30 CAPSULE, GELATIN COATED in 1 BOTTLE

* 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 0480-4490-00 identifies a specific commercial package of 19950 capsule, gelatin coated in 1 box of Tasimelteon, a human prescription drug labeled by Teva Pharmaceuticals, Inc.. This capsule, gelatin coated 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 Teva Pharmaceuticals, Inc. on December 29, 2022. 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 Teva Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00480449000. 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)
0480-4490-00
11-Digit CMS (5-4-2)
00480-4490-00

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