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  4. NDC Product Code: 13533-318 Hyperrab

NDC 13533-318 Hyperrab

Rabies Immune Globulin (human) Injection, Solution Infiltration; Intramuscular - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 13533-318?
  5. Hyperrab Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
13533-318
Proprietary Name:
Hyperrab
Non-Proprietary Name: [1]
Rabies Immune Globulin (human)
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]
  • Infiltration - Administration that results in substances passing into tissue spaces or into cells.
  • Intramuscular - Administration within a muscle.
    • Labeler Name: [5]
    Grifols Usa, Llc
    Labeler Code:
    13533
    Product Label ID:
    f82880b8-998c-4659-8f20-6dcc81f258e9
    FDA Application Number: [6]
    BLA101144
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    06-12-1974
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - COLORLESS OR PALE YELLOW OR LIGHT BROWN)

    Product Packages

    NDC Code 13533-318-01

    Package Description: 1 VIAL in 1 CARTON / 1 mL in 1 VIAL (13533-318-10)

    NDC Code 13533-318-03

    Package Description: 1 VIAL in 1 CARTON / 3 mL in 1 VIAL (13533-318-30)

    NDC Code 13533-318-05

    Package Description: 1 VIAL in 1 CARTON / 5 mL in 1 VIAL (13533-318-50)

    Product Details

    What is NDC 13533-318?

    The NDC code 13533-318 is assigned by the FDA to the product Hyperrab which is a plasma derivative product labeled by Grifols Usa, Llc. The generic name of Hyperrab is rabies immune globulin (human). The product's dosage form is injection, solution and is administered via infiltration; intramuscular form. The product is distributed in 3 packages with assigned NDC codes 13533-318-01 1 vial in 1 carton / 1 ml in 1 vial (13533-318-10), 13533-318-03 1 vial in 1 carton / 3 ml in 1 vial (13533-318-30), 13533-318-05 1 vial in 1 carton / 5 ml in 1 vial (13533-318-50). 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 Hyperrab?

    HYPERRAB is a human rabies immune globulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. Limitation of UsePersons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine.(1-3)For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis.(1-3)Beyond 7 days (after the first vaccine dose), HYPERRAB is not indicated since an antibody response to vaccine is presumed to have occurred.

    What are Hyperrab 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 Hyperrab 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 Hyperrab 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 Hyperrab?

    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: 2043306 - rabies immune globulin, human 300 UNT in 1 mL Injection
    • RxCUI: 2043306 - 1 ML rabies immune globulin, human 300 UNT/ML Injection
    • RxCUI: 2043306 - rabies immune globulin, human 300 UNT per 1 ML Injection
    • RxCUI: 2043308 - HyperRAB 300 UNT in 1 mL Injection
    • RxCUI: 2043308 - 1 ML rabies immune globulin, human 300 UNT/ML Injection [HyperRAB]

    * 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".