NDC Package 13533-634-02 Hypertet

Tetanus Immune Globulin (human) Injection Intramuscular - View Billable Units, 11-Digit Format, RxNorm

Package Information
NDC HCPCS Crosswalk
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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

Proprietary Name:

Hypertet

Non-Proprietary Name:

Tetanus Immune Globulin (human)

Substance Name:

Human Clostridium Tetani Toxoid Immune Globulin

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

11-Digit NDC Billing Format:

13533063402

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to 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]

Product Type:

Plasma Derivative

Labeler Name:

Grifols Usa, Llc

Dosage Form:

Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

Administration Route(s):

Intramuscular - Administration within a muscle.

Active Ingredient(s):

HUMAN CLOSTRIDIUM TETANI TOXOID IMMUNE GLOBULIN 250 [iU]/mL

Sample Package:

FDA Application Number:

BLA101142

Marketing Category:

BLA - A product marketed under an approved Biologic License Application.

Start Marketing Date:

08-14-1996

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

13533 - Grifols Usa, Llc
- 13533-634 - Hypertet
  - 13533-634-02 - 1 SYRINGE, GLASS in 1 BOX / 1 mL in 1 SYRINGE, GLASS (13533-634-20)

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 disclaimer below.

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 13533-634-02 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
13533063402	J1670	Tetanus immune globulin inj	250 UNITS	1	1	1	1

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 13533-634-02?

The NDC Packaged Code 13533-634-02 is assigned to a 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. The product's dosage form is injection and is administered via intramuscular form.

Is NDC 13533-634 included in the NDC Directory?

Yes, Hypertet with product code 13533-634 is active and included in the NDC Directory. The product was first marketed by Grifols Usa, Llc on August 14, 1996 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 13533-634-02?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 13533-634-02?

The 11-digit format is 13533063402. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	13533-634-02	5-4-2	13533-0634-02

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