Veklury Injection, Powder, Lyophilized, For Solution
NDC Package 61958-2901-2

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

Veklury (remdesivir) injection is vEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, who are [see Clinical Studies (14)]:Hospitalized, orNot hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Gilead Sciences, Inc., this product is identified by NDC 61958-2901 and is authorized under FDA application NDA214787.

Identification & Billing

NDC Package Code
61958-2901-2
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Product Code
61958-2901
11-Digit Billing Format
61958290102
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Veklury
Non-Proprietary Name
Remdesivir
Substance Name
Remdesivir
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
REMDESIVIR 100 mg/1
Pharmacologic Class
SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor - [EPC] (Established Pharmacologic Class)
Usage Information
VEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, who are [see Clinical Studies (14)]:Hospitalized, orNot hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.

Regulatory & Marketing

Labeler Name
Gilead Sciences, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214787
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61958-2901). Click a package code to view its specific billing and regulatory data.

61958-2901-1
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

* 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 61958-2901-2 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose of Veklury, a human prescription drug labeled by Gilead Sciences, Inc.. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains remdesivir 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 November 01, 2020. The current certification is valid through December 31, 2027.

How is this Gilead Sciences, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61958290102. 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 (5-4-1)
61958-2901-2
11-Digit CMS (5-4-2)
61958-2901-02

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