Zemaira Kit
NDC 0053-7202
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Zemaira (.alpha.1-proteinase inhibitor human) is a BLA-approved product labeled by Csl Behring Llc. This medication is used to treat lung problems (emphysema) caused by a certain inherited disease (alpha-1-proteinase inhibitor deficiency). It is supplied as a kit. This product entry covers the primary NDC 0053-7202 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0053-7202
Proprietary Name:
Zemaira
Non-Proprietary Name: [1]
.alpha.1-proteinase Inhibitor Human
NDC Directory Status:
Plasma Derivative
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Kit
- A packaged collection of related material.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0053
Product Label ID:
FDA Application Number: [6]
BLA125078
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
04-24-2019
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 0053-7202?
The NDC code 0053-7202 is assigned by the FDA to the product Zemaira. It is commonly known by its generic name, .alpha.1-proteinase inhibitor human. This pharmaceutical product is labeled by Csl Behring Llc and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0053-7202-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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.
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 1661208 - alpha 1-proteinase inhibitor, human 1 MG Injection
- RxCUI: 991722 - Zemaira 1 MG Injection
- RxCUI: 991722 - alpha 1-proteinase inhibitor, human 1 MG Injection [Zemaira]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
