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NDC 13533-634 Hypertet

Tetanus Immune Globulin (human) Injection Intramuscular - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 13533-634?
  5. Hypertet Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
13533-634
Proprietary Name:
Hypertet
Non-Proprietary Name: [1]
Tetanus Immune Globulin (human)
Substance Name: [2]
Human Clostridium Tetani Toxoid Immune Globulin
NDC Directory Status:
Plasma Derivative
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
    • Labeler Name: [5]
    Grifols Usa, Llc
    Labeler Code:
    13533
    Product Label ID:
    393fa198-7e07-4162-bd0a-9d873f1544a9
    FDA Application Number: [6]
    BLA101142
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    08-14-1996
    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 13533-634-02

    Package Description: 1 SYRINGE, GLASS in 1 BOX / 1 mL in 1 SYRINGE, GLASS (13533-634-20)

    Product Details

    What is NDC 13533-634?

    The NDC code 13533-634 is assigned by the FDA to the product Hypertet which is a plasma derivative product labeled by Grifols Usa, Llc. The generic name of Hypertet is tetanus immune globulin (human). The product's dosage form is injection and is administered via intramuscular form. The product is distributed in a single package with assigned NDC code 13533-634-02 1 syringe, glass in 1 box / 1 ml in 1 syringe, glass (13533-634-20). 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 Hypertet?

    HyperTET is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain (see below). It is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus.(8,9,16)A thorough attempt must be made to determine whether a patient has completed primary vaccination. Patients with unknown or uncertain previous vaccination histories should be considered to have had no previous tetanus toxoid doses. Persons who had military service since 1941 can be considered to have received at least one dose, and although most of them may have completed a primary series of tetanus toxoid, this cannot be assumed for each individual. Patients who have not completed a primary series may require tetanus toxoid and passive immunization at the time of wound cleaning and debridement.(3)The following table is a summary guide to tetanus prophylaxis in wound management:Guide to Tetanus Prophylaxis in Wound Management(3 )History of Tetanus Immunization (Doses)Clean, Minor WoundsAll Other WoundsSuch as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns and frostbite.Td Adult type tetanus and diphtheria toxoids. If the patient is less than 7 years old, DT or DTP is preferred to tetanus toxoid alone. For persons ≥7 years of age, Td is preferred to tetanus toxoid alone. (see Dosage and Administration)TIGTetanus Immune Globulin (Human).TdTIG    Uncertain or less than 3YesNoYesYes    3 or moreIf only three doses of fluid tetanus toxoid have been received, a fourth dose of toxoid, preferably an adsorbed toxoid, should be given.NoYes if more than 10 years since the last dose.NoNoYes if more than 5 years since the last dose. (More frequent boosters are not needed and can accentuate side effects).No

    What are Hypertet 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 Hypertet UNII Codes?

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

    • HUMAN CLOSTRIDIUM TETANI TOXOID IMMUNE GLOBULIN (UNII: V4SWI4RF4J)
    • HUMAN CLOSTRIDIUM TETANI TOXOID IMMUNE GLOBULIN (UNII: V4SWI4RF4J) (Active Moiety)

    Which are Hypertet 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 Hypertet?

    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: 1087391 - tetanus immune globulin, human 250 UNT in 1 ML Prefilled Syringe
    • RxCUI: 1087391 - 1 ML tetanus immune globulin, human 250 UNT/ML Prefilled Syringe
    • RxCUI: 1087391 - tetanus immune globulin, human 250 UNT per 1 ML Prefilled Syringe
    • RxCUI: 1087395 - Hypertet 250 UNT in 1 ML Prefilled Syringe
    • RxCUI: 1087395 - 1 ML tetanus immune globulin, human 250 UNT/ML Prefilled Syringe [Hypertet]

    * 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".