Tdvax
NDC Package 13533-131-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Tdvax is this vaccine is used to help prevent problems that may occur with 2 bacterial infections in children and adults (tetanus and diphtheria). Marketed by Grifols Usa, Llc, this product is identified by NDC 13533-131 and is authorized under FDA application BLA101322.

Identification & Billing

NDC Package Code
13533-131-01
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE (13533-131-00)
Product Code
13533-131
11-Digit Billing Format
13533013101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Tdvax
Dosage Form
-
Usage Information
This vaccine is used to help prevent problems that may occur with 2 bacterial infections in children and adults (tetanus and diphtheria). Tetanus (lockjaw) and diphtheria can cause serious, sometimes fatal problems (heart problems, nerve problems, muscle paralysis). Vaccination is the best way to protect (provide immunity) against these life-threatening diseases. Vaccines work by getting the body to make its own protection (antibodies). This vaccine is recommended for all people 7 years and older. Diphtheria and tetanus toxoids combined (adult) injection should not be used in anyone younger than 7 years because they may not be fully protected by this vaccine. A vaccine for children younger than 7 years is available. Consult your child's health care professional for more information.

Regulatory & Marketing

Labeler Name
Grifols Usa, Llc
FDA Application #
BLA101322
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-27-1970
End Marketing Date
03-31-2025
Listing Expiration
03-31-2025
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 13533-131-01 identifies a specific commercial package of 10 vial, single-dose in 1 carton / .5 ml in 1 vial, single-dose (13533-131-00) of Tdvax, labeled by Grifols Usa, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Grifols Usa, Llc on July 27, 1970. The current certification is valid through March 31, 2025.

What are the primary indications for this medication?

This vaccine is used to help prevent problems that may occur with 2 bacterial infections in children and adults (tetanus and diphtheria). Tetanus (lockjaw) and diphtheria can cause serious, sometimes fatal problems (heart problems, nerve problems, muscle paralysis). Vaccination is the best way to protect (provide immunity) against these life-threatening diseases. Vaccines work by getting the body to make its own protection (antibodies). This vaccine is recommended for all people 7 years and older. Diphtheria and tetanus toxoids combined (adult) injection should not be used in anyone younger than 7 years because they may not be fully protected by this vaccine. A vaccine for children younger than 7 years is available. Consult your child's health care professional for more information.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13533013101. 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)
13533-131-01
11-Digit CMS (5-4-2)
13533-0131-01

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