NDC 49281-190-20 Imogam Rabies-ht
Human Rabies Virus Immune Globulin Injection, Solution Intramuscular

Package Information

The NDC Code 49281-190-20 is assigned to a package of 1 vial, single-dose in 1 carton > 2 ml in 1 vial, single-dose (49281-190-58) of Imogam Rabies-ht, a plasma derivative labeled by Sanofi Pasteur Inc.. The product's dosage form is injection, solution and is administered via intramuscular form.This product is billed per "ML" milliliter and contains an estimated amount of 2 billable units per package.

Field Name Field Value
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 Code 49281-190
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Imogam Rabies-ht
Non-Proprietary Name 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.
Human Rabies Virus Immune Globulin
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
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.
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
49281019020
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package 2 ML
NDC to 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: 830477 - Imogam Rabies-HT 150 UNT/ML in 2 ML Injection
  • RxCUI: 830477 - 2 ML rabies immune globulin, human 150 UNT/ML Injection [Imogam]
  • Product Type 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.
    Plasma Derivative
    Labeler Name Sanofi Pasteur Inc.
    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)
    • Intramuscular - Administration within a muscle.
    Active Ingredient(s)
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    No
    Marketing Category 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.
    BLA - A product marketed under an approved Biologic License Application.
    FDA Application Number 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.
    BLA103932
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    04-27-1984
    Listing Expiration Date 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.
    12-31-2022
    Exclude Flag 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".
    N
    NDC Code Structure

    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.

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    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 49281-190-20 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    4928101902090376Rabies ig heat treated150 IU2122

    * Please review the disclaimer below.