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  5. NDC Package Code: 57516-101-02 Zemaira

NDC Package 57516-101-02 Zemaira

Alpha-1-proteinase Inhibitor Human Kit Kit Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Zemaira
Non-Proprietary Name:
Alpha-1-proteinase Inhibitor Human Kit
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.
11-Digit NDC Billing Format:
57516010102
NDC to RxNorm Crosswalk:
Product Type:
Plasma Derivative
Labeler Name:
Fisher Clinical Services Inc.
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s):
Intravenous - Administration within or into a vein or veins.
Sample Package:
No
FDA Application Number:
BLA125078
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
02-22-2022
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 57516-101-02?

The NDC Packaged Code 57516-101-02 is assigned to a 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.. The product's dosage form is kit and is administered via intravenous form.

Is NDC 57516-101 included in the NDC Directory?

Yes, Zemaira with product code 57516-101 is active and included in the NDC Directory. The product was first marketed by Fisher Clinical Services Inc. on February 22, 2022 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 57516-101-02?

The 11-digit format is 57516010102. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-257516-101-025-4-257516-0101-02