Tezspire Injection, Solution
NDC Package 55513-112-01

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

Tezspire (tezepelumab-ekko) injection is tEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.Limitations of Use:TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. This formulation utilizes a injection, solution delivery system. Marketed by Amgen Inc, this product is identified by NDC 55513-112 and is authorized under FDA application BLA761224.

Identification & Billing

NDC Package Code
55513-112-01
Package Description
1 SYRINGE in 1 CARTON / 1.91 mL in 1 SYRINGE
Product Code
55513-112
11-Digit Billing Format
55513011201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tezspire
Non-Proprietary Name
Tezepelumab-ekko
Substance Name
Tezepelumab
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
TEZEPELUMAB 210 mg/1.9mL
Pharmacologic Class
Usage Information
TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.Limitations of Use:TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.

Regulatory & Marketing

Labeler Name
Amgen Inc
Product Type
Human Prescription Drug
FDA Application #
BLA761224
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-17-2021
Listing Expiration
12-31-2026
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 (55513-112). Click a package code to view its specific billing and regulatory data.

55513-112-96
1 SYRINGE in 1 CARTON / 1.91 mL in 1 SYRINGE
55513-112-99
1.91 mL in 1 SYRINGE

* 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 55513-112-01 identifies a specific commercial package of 1 syringe in 1 carton / 1.91 ml in 1 syringe of Tezspire, a human prescription drug labeled by Amgen Inc. This injection, solution is formulated for subcutaneous use and contains tezepelumab 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 Amgen Inc on December 17, 2021. The current certification is valid through December 31, 2026.

How is this Amgen Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55513011201. 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)
55513-112-01
11-Digit CMS (5-4-2)
55513-0112-01

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