Hypertet Injection
NDC Package 13533-634-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Hypertet (tetanus immune globulin (human)) injection is hyperTET is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain (see below). This formulation utilizes a injection delivery system. Marketed by Grifols Usa, Llc, this product is identified by NDC 13533-634 and is authorized under FDA application BLA101142.

Identification & Billing

NDC Package Code
13533-634-02
Package Description
1 SYRINGE, GLASS in 1 BOX / 1 mL in 1 SYRINGE, GLASS (13533-634-20)
Product Code
13533-634
11-Digit Billing Format
13533063402
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • 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]

Clinical Specifications

Proprietary Name
Hypertet
Non-Proprietary Name
Tetanus Immune Globulin (human)
Substance Name
Human Clostridium Tetani Toxoid Immune Globulin
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
HUMAN CLOSTRIDIUM TETANI TOXOID IMMUNE GLOBULIN 250 [iU]/mL
Usage Information
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

Regulatory & Marketing

Labeler Name
Grifols Usa, Llc
Product Type
Plasma Derivative
FDA Application #
BLA101142
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-14-1996
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1670
Source: ASP
Tetanus immune globulin inj
HCPCS Dosage 250 UNITS
Units / Pkg 1

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 13533-634-02 identifies a specific commercial package of 1 syringe, glass in 1 box / 1 ml in 1 syringe, glass (13533-634-20) of Hypertet, a plasma derivative labeled by Grifols Usa, Llc. This injection is formulated for intramuscular use and contains human clostridium tetani toxoid immune globulin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Grifols Usa, Llc on August 14, 1996. The current certification is valid through December 31, 2026.

How is this Grifols Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13533063402. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
13533-634-02
11-Digit CMS (5-4-2)
13533-0634-02

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.