Sivextro Injection, Powder, Lyophilized, For Solution
NDC Package 67919-040-02

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

Package Information

Sivextro (tedizolid phosphate) injection is a medication used to treat serious bacterial infections of the skin. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 67919-040 and is authorized under FDA application NDA205436.

Identification & Billing

NDC Package Code
67919-040-02
Package Description
10 VIAL, GLASS in 1 CARTON / 4 mL in 1 VIAL, GLASS
Product Code
67919-040
11-Digit Billing Format
67919004002
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sivextro
Non-Proprietary Name
Tedizolid Phosphate
Substance Name
Tedizolid Phosphate
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)
TEDIZOLID PHOSPHATE 200 mg/4mL
Pharmacologic Class
Usage Information
This medication is used to treat serious bacterial infections of the skin. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Llc
Product Type
Human Prescription Drug
FDA Application #
NDA205436
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-20-2014
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 67919-040-02 identifies a specific commercial package of 10 vial, glass in 1 carton / 4 ml in 1 vial, glass of Sivextro, a human prescription drug labeled by Merck Sharp & Dohme Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains tedizolid phosphate 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 June 20, 2014. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat serious bacterial infections of the skin. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

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: 67919004002. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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:

10-Digit Format (5-3-2)
67919-040-02
11-Digit CMS (5-4-2)
67919-0040-02

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