Tpoxx Injection, Solution, Concentrate
NDC Package 50072-010-01

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

Package Information

Tpoxx (tecovirimat monohydrate) injection is none. This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Siga Technologies, Inc., this product is identified by NDC 50072-010 and is authorized under FDA application NDA214518.

Identification & Billing

NDC Package Code
50072-010-01
Package Description
7 VIAL in 1 CARTON / 20 mL in 1 VIAL (50072-010-30)
Product Code
50072-010
11-Digit Billing Format
50072001001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tpoxx
Non-Proprietary Name
Tecovirimat Monohydrate
Substance Name
Tecovirimat
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TECOVIRIMAT 10 mg/mL
Pharmacologic Class
Usage Information
None.

Regulatory & Marketing

Labeler Name
Siga Technologies, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214518
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-31-2022
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 50072-010-01 identifies a specific commercial package of 7 vial in 1 carton / 20 ml in 1 vial (50072-010-30) of Tpoxx, a human prescription drug labeled by Siga Technologies, Inc.. This injection, solution, concentrate is formulated for intravenous use and contains tecovirimat 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 Siga Technologies, Inc. on May 31, 2022. The current certification is valid through December 31, 2027.

How is this Siga Technologies, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50072001001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
50072-010-01
11-Digit CMS (5-4-2)
50072-0010-01

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