Kedrab Injection, Solution
NDC Package 76125-150-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Kedrab (human rabies virus immune globulin) injection is 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. This formulation utilizes a injection, solution delivery system. Marketed by Kedrion Biopharma Inc., this product is identified by NDC 76125-150 and is authorized under FDA application BLA125613.

Identification & Billing

NDC Package Code
76125-150-10
Package Description
1 VIAL, GLASS in 1 BOX / 10 mL in 1 VIAL, GLASS (76125-150-11)
Product Code
76125-150
11-Digit Billing Format
76125015010
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Kedrab
Non-Proprietary Name
Human Rabies Virus Immune Globulin
Substance Name
Human Rabies Virus Immune Globulin
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
Intramuscular - Administration within a muscle.
Active Ingredient(s)
HUMAN RABIES VIRUS IMMUNE GLOBULIN 150 [iU]/mL
Usage Information
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

Regulatory & Marketing

Labeler Name
Kedrion Biopharma Inc.
Product Type
Plasma Derivative
FDA Application #
BLA125613
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-08-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76125-150). Click a package code to view its specific billing and regulatory data.

76125-150-02
1 VIAL, GLASS in 1 BOX / 2 mL in 1 VIAL, GLASS (76125-150-03)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76125-150-10 identifies a specific commercial package of 1 vial, glass in 1 box / 10 ml in 1 vial, glass (76125-150-11) of Kedrab, a plasma derivative labeled by Kedrion Biopharma Inc.. This injection, solution is formulated for intramuscular use and contains human rabies virus immune globulin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Kedrion Biopharma Inc. on November 08, 2017. The current certification is valid through December 31, 2026.

How is this Kedrion Biopharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76125015010. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
76125-150-10
11-Digit CMS (5-4-2)
76125-0150-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.