NDC 0053-7203 Zemaira

.alpha.1-proteinase Inhibitor Human Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0053-7203
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
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Csl Behring Llc
Labeler Code:
0053
FDA Application Number: [6]
BLA125078
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
04-24-2019
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Packages

NDC Code 0053-7203-02

Package Description: 1 KIT in 1 CARTON * 95 mL in 1 VIAL, SINGLE-USE (0053-7213-01) * 95 mL in 1 VIAL, SINGLE-USE (0053-7653-12)

Product Details

What is NDC 0053-7203?

The NDC code 0053-7203 is assigned by the FDA to the product Zemaira which is a plasma derivative product labeled by Csl Behring Llc. The generic name of Zemaira is .alpha.1-proteinase inhibitor human. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0053-7203-02 1 kit in 1 carton * 95 ml in 1 vial, single-use (0053-7213-01) * 95 ml in 1 vial, single-use (0053-7653-12). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Zemaira?

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 Zemaira?

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:

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Product Footnotes

[1] 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.

[3] 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.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".