Hypertet Injection
NDC 13533-634

View dosage, usage, ingredients, routes, and UNII mappings.

Product Information

Hypertet (tetanus immune globulin (human)) is a BLA-approved product labeled by Grifols Usa, Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a yellow injection for intramuscular administration. This product entry covers the primary NDC 13533-634 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Labeler Code:
13533
HCPCS Code:
J1670 - INJECTION, TETANUS IMMUNE GLOBULIN, HUMAN, UP TO 250 UNITS
FDA Application Number: [6]
BLA101142
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
08-14-1996
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

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

Code Structure Chart

Product Details

What is NDC 13533-634?

The NDC code 13533-634 is assigned by the FDA to the product Hypertet. It is commonly known by its generic name, tetanus immune globulin (human). This pharmaceutical product is labeled by Grifols Usa, Llc and is currently categorized as listed product. The medication is a injection administered via intramuscular route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 13533-634-02. 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?

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 Active Ingredients of this product?

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 the associated 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 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: 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]

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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 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.
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 are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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".