Winrevair Kit
NDC Package 0006-5091-01

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

Package Information

Winrevair (sotatercept-csrk) kits is wINREVAIR™ is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. This formulation utilizes a kit delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 0006-5091 and is authorized under FDA application BLA761363.

Identification & Billing

NDC Package Code
0006-5091-01
Package Description
1 KIT in 1 CARTON * 1 mL in 1 VIAL, SINGLE-DOSE (0006-5069-99) * 1.3 mL in 1 SYRINGE (0006-5080-89)
Product Code
0006-5091
11-Digit Billing Format
00006509101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Winrevair
Non-Proprietary Name
Sotatercept-csrk
Dosage Form
Kit - A packaged collection of related material.
Usage Information
WINREVAIR™ is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events.

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Llc
Product Type
Human Prescription Drug
FDA Application #
BLA761363
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-26-2024
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 0006-5091-01 identifies a specific commercial package of 1 kit in 1 carton * 1 ml in 1 vial, single-dose (0006-5069-99) * 1.3 ml in 1 syringe (0006-5080-89) of Winrevair, a human prescription drug labeled by Merck Sharp & Dohme Llc. This kit is formulated for 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 Merck Sharp & Dohme Llc on March 26, 2024. The current certification is valid through December 31, 2027.

How is this Merck Sharp & Dohme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00006509101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
0006-5091-01
11-Digit CMS (5-4-2)
00006-5091-01

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