Letairis Tablet, Film Coated
NDC Package 61958-0801-2
Package Information
Letairis (ambrisentan) tablets is ambrisentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This formulation utilizes a tablet, film coated delivery system. Marketed by Gilead Sciences, Inc., this product is identified by NDC 61958-0801 and is authorized under FDA application NDA022081.
Identification & Billing
- RxCUI: 722116 - ambrisentan 10 MG Oral Tablet
- RxCUI: 722120 - Letairis 10 MG Oral Tablet
- RxCUI: 722120 - ambrisentan 10 MG Oral Tablet [Letairis]
- RxCUI: 722122 - ambrisentan 5 MG Oral Tablet
- RxCUI: 722124 - Letairis 5 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 61958 - Gilead Sciences, Inc.
- 61958-0801 - Letairis
- 61958-0801-2 - 3 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK
- 61958-0801 - Letairis
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 (61958-0801). Click a package code to view its specific billing and regulatory data.
* 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 61958-0801-2 identifies a specific commercial package of 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack of Letairis, a human prescription drug labeled by Gilead Sciences, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 3 billable units per package. This tablet, film coated is formulated for oral use and contains ambrisentan 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 Gilead Sciences, Inc. on June 15, 2007. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
Ambrisentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This condition is thought to be caused by increased levels of a certain natural substance (endothelin-1). This medication blocks the effects of endothelin-1, thereby helping to decrease the blood pressure in the lungs, slow the worsening of symptoms, and improve your ability to exercise.
How is this Gilead Sciences, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 61958080102. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
