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  4. NDC Product Code: 76179-025 Kedbumin

NDC 76179-025 Kedbumin

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 76179-025?
  5. Kedbumin Uses
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing expired due to lack of listing certification.

Get all the details for National Drug Code (NDC) 76179-025 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
76179-025
Proprietary Name:
Kedbumin
Product Type: [3]
Labeler Name: [5]
Kedrion S.p.a
Labeler Code:
76179
Product Label ID:
57bd6811-8619-11e0-9d78-0800200c9a66
HCPCS Code:
P9046 - Albumin (human), 25%, 20 ml
FDA Application Number: [6]
BLA125384
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
09-15-2011
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
U
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - ALMOST CLEAR AND COLOURLESS)
GREEN (C48329 - ALMOST CLEAR AND COLOURLESS)

Code Structure Chart

Product Details

What is NDC 76179-025?

The NDC code 76179-025 is assigned by the FDA to the product Kedbumin which is product labeled by Kedrion S.p.a. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 76179-025-02 1 vial, glass in 1 carton / 50 ml in 1 vial, glass (76179-025-01), 76179-025-04 1 vial in 1 carton / 100 ml in 1 vial (76179-025-03). 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 Kedbumin?

KEDBUMIN® is contraindicated in patients with a history of hypersensitivity to albumin, excipients used in its formulation, or components of the container [11].KEDBUMIN® is also contraindicated in severely anemic patients and in patients with heart failure.

Which are Kedbumin UNII Codes?

The UNII codes for the active ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Kedbumin?

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

[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, 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".