Zemaira Kit
NDC Package 57516-101-02

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

Package Information

Zemaira (alpha-1-proteinase inhibitor human kit) kits is a medication used to treat lung problems (emphysema) caused by a certain inherited disease (alpha-1-proteinase inhibitor deficiency). This formulation utilizes a kit delivery system. Marketed by Fisher Clinical Services Inc., this product is identified by NDC 57516-101 and is authorized under FDA application BLA125078.

Identification & Billing

NDC Package Code
57516-101-02
Package Description
1 KIT in 1 CARTON * 20 mL in 1 VIAL, SINGLE-DOSE (57516-102-01) * 20 mL in 1 VIAL, SINGLE-DOSE (57516-103-20)
Product Code
57516-101
11-Digit Billing Format
57516010102
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zemaira
Non-Proprietary Name
Alpha-1-proteinase Inhibitor Human Kit
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Intravenous - Administration within or into a vein or veins.
Usage Information
This medication is used to treat lung problems (emphysema) caused by a certain inherited disease (alpha-1-proteinase inhibitor deficiency). In people with this condition, lung damage is caused by elastase, a natural substance that the body needs to kill bacteria in the lungs. Normally, a protein (alpha-1-proteinase inhibitor) stops elastase from working when it is no longer needed. However, in people who do not make enough of this protein, elastase does not stop working and damages the lungs. This medication replaces the missing alpha-1-proteinase inhibitor and helps to prevent further lung damage.

Regulatory & Marketing

Labeler Name
Fisher Clinical Services Inc.
Product Type
Plasma Derivative
FDA Application #
BLA125078
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-22-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 57516-101-02 identifies a specific commercial package of 1 kit in 1 carton * 20 ml in 1 vial, single-dose (57516-102-01) * 20 ml in 1 vial, single-dose (57516-103-20) of Zemaira, a plasma derivative labeled by Fisher Clinical Services Inc.. This kit is formulated for intravenous use and contains 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 Fisher Clinical Services Inc. on February 22, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat lung problems (emphysema) caused by a certain inherited disease (alpha-1-proteinase inhibitor deficiency). In people with this condition, lung damage is caused by elastase, a natural substance that the body needs to kill bacteria in the lungs. Normally, a protein (alpha-1-proteinase inhibitor) stops elastase from working when it is no longer needed. However, in people who do not make enough of this protein, elastase does not stop working and damages the lungs. This medication replaces the missing alpha-1-proteinase inhibitor and helps to prevent further lung damage.

How is this Fisher Clinical Services Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57516010102. 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)
57516-101-02
11-Digit CMS (5-4-2)
57516-0101-02

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