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NDC 49281-190 Imogam Rabies-ht

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 49281-190?
  4. Imogam Rabies-ht Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
49281-190
Proprietary Name:
Imogam Rabies-ht
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]
    Sanofi Pasteur Inc.
    Labeler Code:
    49281
    Product Label ID:
    bf845cf8-7c01-46c0-97cb-e73a121ff3a7
    FDA Application Number: [6]
    BLA103932
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    04-27-1984
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 49281-190-20

    Package Description: 1 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (49281-190-58)

    Product Details

    What is NDC 49281-190?

    The NDC code 49281-190 is assigned by the FDA to the product Imogam Rabies-ht which is a plasma derivative product labeled by Sanofi Pasteur Inc.. The generic name of Imogam Rabies-ht 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 a single package with assigned NDC code 49281-190-20 1 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose (49281-190-58). 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 Imogam Rabies-ht?

    Rabies Immune Globulin (Human) Heat Treated, Imogam Rabies – HT, in conjunction with the standard series of Rabies Vaccine vaccinations, is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with Rabies Vaccine. Previously immunized persons are those who have had a documented rabies virus neutralizing antibody titer and who have completed one of the recommended regimens (pre-exposure or post-exposure) with a cell culture vaccine or another vaccine. Administer only vaccine to these persons (i.e., post-exposure for a person previously vaccinated). (1)Inject Imogam Rabies – HT, as promptly as possible after exposure, along with the first dose of vaccine. If initiation of treatment is delayed for any reason, still administer Imogam Rabies – HT and the first dose of vaccine, regardless of the interval between exposure and treatment. If Rabies Immune Globulin (Human) was not administered when vaccination was begun (i.e., day 0), it can be administered up to and including day 7 of the post-exposure prophylaxis series. (1)In order to manage potential human exposures to rabies appropriately, the risk of infection must be accurately assessed. Rabies virus is usually transmitted by the bite of a rabid animal (dog, bat, etc.) but can occasionally penetrate abraded skin contaminated with the saliva of infected animals. Progress of the virus after exposure is believed to follow a neural pathway, and the time between exposure and clinical rabies is a function of the proximity of the bite (or abrasion) to the central nervous system and the dose of virus injected. The incubation is usually 2 to 6 weeks but can be longer. After severe bites about the face, neck, and arms, it may be as short as 10 days. After initiation of the vaccine series (human diploid cell origin), it takes approximately one week for development of immunity to rabies; therefore, the value of immediate passive immunization with rabies antibodies in the form of Rabies Immune Globulin (Human) cannot be overemphasized.Recommendations for passive and active immunization after exposure to an animal suspected of having rabies have been outlined by the WHO (3) and by the United States Public Health Service Advisory Committee on Immunization Practices (ACIP). (1)Centers for Disease Control (CDC) recommendations were derived from data on the safety and efficacy of active and passive rabies immunization from both uncontrolled human and animal studies.

    What are Imogam Rabies-ht 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 Imogam Rabies-ht 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 Imogam Rabies-ht 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 Imogam Rabies-ht?

    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: 830477 - Imogam Rabies-HT 150 UNT/ML in 2 ML Injection
    • RxCUI: 830477 - 2 ML rabies immune globulin, human 150 UNT/ML Injection [Imogam]

    * 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".