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  4. NDC Product Code: 76125-150 Kedrab

NDC 76125-150 Kedrab

Human Rabies Virus Immune Globulin Injection, Solution Intramuscular - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 76125-150?
  4. Kedrab Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
76125-150
Proprietary Name:
Kedrab
Non-Proprietary Name: [1]
Human Rabies Virus Immune Globulin
Substance Name: [2]
Human Rabies Virus Immune Globulin
NDC Directory Status:
Plasma Derivative
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
    • Labeler Name: [5]
    Kedrion Biopharma Inc.
    Labeler Code:
    76125
    Product Label ID:
    53f2a23b-c479-4c24-8cab-ee7a33a2633e
    FDA Application Number: [6]
    BLA125613
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    11-08-2017
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 76125-150?

    The NDC code 76125-150 is assigned by the FDA to the product Kedrab which is a plasma derivative product labeled by Kedrion Biopharma Inc.. The generic name of Kedrab is human rabies virus immune globulin. The product's dosage form is injection, solution and is administered via intramuscular form. The product is distributed in 2 packages with assigned NDC codes 76125-150-02 1 vial, glass in 1 box / 2 ml in 1 vial, glass (76125-150-03), 76125-150-10 1 vial, glass in 1 box / 10 ml in 1 vial, glass (76125-150-11). 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 Kedrab?

    KEDRAB is a human rabies immunoglobulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine. Do not administer additional (repeat) doses of KEDRAB once vaccine treatment has been initiated, since this may interfere with the immune response to the rabies vaccine. Do not administer KEDRAB to patients with a history of a complete pre-exposure or post-exposure vaccination regimen and confirmed adequate rabies antibody titer.1

    What are Kedrab Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Kedrab UNII Codes?

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

    • HUMAN RABIES VIRUS IMMUNE GLOBULIN (UNII: 95F619ATQ2)
    • HUMAN RABIES VIRUS IMMUNE GLOBULIN (UNII: 95F619ATQ2) (Active Moiety)

    Which are Kedrab Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Kedrab?

    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: 1652827 - rabies immune globulin, human 150 UNT/ML in 2 ML Injection
    • RxCUI: 1652827 - 2 ML rabies immune globulin, human 150 UNT/ML Injection
    • RxCUI: 1652827 - rabies immune globulin, human 150 UNT/ML per 2 ML Injection
    • RxCUI: 1652833 - rabies immune globulin, human 150 UNT/ML in 10 ML Injection
    • RxCUI: 1652833 - 10 ML rabies immune globulin, human 150 UNT/ML Injection

    * Please review the disclaimer below.

    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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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".