Rabavert Kit
NDC 50632-010

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 50632-010?
  4. Rabavert Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

Rabavert (rabies vaccine) is a BLA-approved product labeled by Bavarian Nordic A/s. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a kit. This product entry covers the primary NDC 50632-010 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
50632-010
Proprietary Name:
Rabavert
Non-Proprietary Name: [1]
Rabies Vaccine
NDC Directory Status:
Vaccine
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]
Bavarian Nordic A/s
Labeler Code:
50632
Product Label ID:
84b7a672-eeb1-4527-84ac-68196b156be2
FDA Application Number: [6]
BLA103334
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
11-11-1997
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 50632-010?

The NDC code 50632-010 is assigned by the FDA to the product Rabavert. It is commonly known by its generic name, rabies vaccine. This pharmaceutical product is labeled by Bavarian Nordic A/s 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: 50632-010-01. 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?

RabAvert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups. Usually an immunization series is initiated and completed with 1 vaccine product. No clinical studies have been conducted that document a change in efficacy or the frequency of adverse reactions when the series is completed with a second vaccine product. However, for booster immunization, RabAvert was shown to elicit protective antibody level responses in persons tested who received a primary series with HDCV.4,11

Which are the associated UNII Codes?

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

  • RABIES VIRUS STRAIN FLURY LEP ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: FK894Q51YE)
  • RABIES VIRUS STRAIN FLURY LEP ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: FK894Q51YE) (Active Moiety)

Which are the Inactive Ingredients associated 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 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: 830460 - rabies virus vaccine (generic for Rabavert) 2.5 UNT in 1 ML Injection
  • RxCUI: 830460 - 1 ML rabies virus vaccine flury-lep strain 2.5 UNT/ML Injection
  • RxCUI: 830460 - rabies virus vaccine flury-lep strain 2.5 UNT per 1 ML Injection
  • RxCUI: 830463 - RabAvert 2.5 UNT in 1 ML Injection
  • RxCUI: 830463 - 1 ML rabies virus vaccine flury-lep strain 2.5 UNT/ML Injection [RabAvert]

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

Patient Education

Rabies Vaccine


What is rabies? Rabies is a serious disease. It is caused by a virus. Rabies is mainly a disease of animals. Humans get rabies when they are bitten by infected animals. At first there might not be any symptoms. But weeks, or even years after a bite, rabies can cause pain, fatigue, headaches, fever, and irritability. These are followed by seizures, hallucinations, and paralysis. Rabies is almost always fatal. Wild animals, especially bats, are the most common source of human rabies infection in the United States. Skunks, raccoons, dogs, and cats can also transmit the disease. Human rabies is rare in the United States. There have been only 55 cases diagnosed since 1990. However, between 16,000 and 39,000 people are treated each year for possible exposure to rabies after animal bites. Also, rabies is far more common in other parts of the world, with about 40,000 to 70,000 rabies-related deaths each year. Bites from unvaccinated dogs cause most of these cases. Rabies vaccine can prevent rabies.
[Learn More]


* 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".