NDC Package 0006-5087-01 Winrevair

Sotatercept-csrk Kit - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

0006-5087-01

Package Description:

1 KIT in 1 CARTON * 1 mL in 1 VIAL, SINGLE-DOSE (0006-5068-99) * 1 mL in 1 SYRINGE (0006-5079-89)

Product Code:

0006-5087

Proprietary Name:

Winrevair

Non-Proprietary Name:

Sotatercept-csrk

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.

11-Digit NDC Billing Format:

00006508701

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

RxCUI: 2678937 - sotatercept-csrk 45 MG Injection
RxCUI: 2678943 - WINREVAIR 45 MG Injection
RxCUI: 2678943 - sotatercept-csrk 45 MG Injection [Winrevair]
RxCUI: 2678943 - Winrevair 45 MG Injection
RxCUI: 2678945 - sotatercept-csrk 60 MG Injection

Product Type:

Human Prescription Drug

Labeler Name:

Merck Sharp & Dohme Llc

Dosage Form:

Kit - A packaged collection of related material.

Sample Package:

FDA Application Number:

BLA761363

Marketing Category:

BLA - A product marketed under an approved Biologic License Application.

Start Marketing Date:

03-26-2024

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

0006 - Merck Sharp & Dohme Llc
- 0006-5087 - Winrevair
  - 0006-5087-01 - 1 KIT in 1 CARTON * 1 mL in 1 VIAL, SINGLE-DOSE (0006-5068-99) * 1 mL in 1 SYRINGE (0006-5079-89)

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 disclaimer below.

Frequently Asked Questions

What is NDC 0006-5087-01?

The NDC Packaged Code 0006-5087-01 is assigned to a package of 1 kit in 1 carton * 1 ml in 1 vial, single-dose (0006-5068-99) * 1 ml in 1 syringe (0006-5079-89) of Winrevair, a human prescription drug labeled by Merck Sharp & Dohme Llc. The product's dosage form is kit and is administered via form.

Is NDC 0006-5087 included in the NDC Directory?

Yes, Winrevair with product code 0006-5087 is active and included in the NDC Directory. The product was first marketed by Merck Sharp & Dohme Llc on March 26, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0006-5087-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

What is the 11-digit format for NDC 0006-5087-01?

The 11-digit format is 00006508701. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0006-5087-01	5-4-2	00006-5087-01

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