Zemaira (alpha-1-proteinase inhibitor human kit) NDC 57516-110

Product information

Brand name (proprietary)

Zemaira

Generic name (nonproprietary)

alpha-1-proteinase inhibitor human kit

Dosage form

Kit

Route

Intravenous

Labeler

Fisher Clinical Services Inc.

Product type

Plasma derivative

Marketing category

BLA — Biologics License ApplicationApplication BLA 125078

Marketing start

Jul 31, 2023

Listing expires

Dec 31, 2026

Identifiers

Product ID 57516-110_31a53b86-857c-a2d9-e063-6394a90abfb8SPL ID 31a53b86-857c-a2d9-e063-6394a90abfb8

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N457516011002 followed by a unit qualifier and the quantity Copy

Package 57516-0110-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under BLA 125078

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.