Tezspire
NDC Package 55513-100-99

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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. Marketed by Amgen Inc, this product is identified by NDC 55513-100 and is authorized under FDA application BLA761224.

Identification & Billing

NDC Package Code
55513-100-99
Package Description
1.91 mL in 1 VIAL, GLASS
Product Code
55513-100
11-Digit Billing Format
55513010099
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tezspire
Dosage Form
-
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
FDA Application #
BLA761224
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-17-2021
End Marketing Date
12-18-2021
Listing Expiration
12-18-2021
Exclude Flag
D
Sample Package
Yes

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 (55513-100). Click a package code to view its specific billing and regulatory data.

55513-100-01
1 VIAL, GLASS in 1 CARTON / 1.91 mL in 1 VIAL, GLASS
55513-100-96
1 VIAL, GLASS in 1 CARTON / 1.91 mL in 1 VIAL, GLASS

* 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 55513-100-99 identifies a specific commercial package of 1.91 ml in 1 vial, glass of Tezspire, labeled by Amgen Inc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Amgen Inc on December 17, 2021. The current certification is valid through December 18, 2021.

How is this Amgen Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55513010099. 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)
55513-100-99
11-Digit CMS (5-4-2)
55513-0100-99

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