Thiotepa Powder
NDC Package 54875-0004-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Thiotepa powders is thiotepa is used to treat cancer. This formulation utilizes a powder delivery system. Marketed by Heraeus Precious Metals Gmbh & Co. Kg, this product is identified by NDC 54875-0004.

Identification & Billing

NDC Package Code
54875-0004-1
Package Description
1 BOTTLE, PLASTIC in 1 BAG / 700 g in 1 BOTTLE, PLASTIC
Product Code
54875-0004
11-Digit Billing Format
54875000401

Clinical Specifications

Proprietary Name
Thiotepa
Non-Proprietary Name
Thiotepa
Substance Name
Thiotepa
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
THIOTEPA 1 g/g
Usage Information
Thiotepa is used to treat cancer. It works by slowing or stopping the growth of cancer cells. Thiotepa is often given into the bladder to treat bladder cancer. Thiotepa is also used with other medications to prevent rejection of a stem cell transplant.

Regulatory & Marketing

Labeler Name
Heraeus Precious Metals Gmbh & Co. Kg
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
05-02-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 54875-0004-1 identifies a specific commercial package of 1 bottle, plastic in 1 bag / 700 g in 1 bottle, plastic of Thiotepa (UNFINISHED drug), a bulk ingredient labeled by Heraeus Precious Metals Gmbh & Co. Kg. This powder is formulated for use and contains thiotepa 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 Heraeus Precious Metals Gmbh & Co. Kg on May 02, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Thiotepa is used to treat cancer. It works by slowing or stopping the growth of cancer cells. Thiotepa is often given into the bladder to treat bladder cancer. Thiotepa is also used with other medications to prevent rejection of a stem cell transplant.

How is this Heraeus Precious Metals Gmbh & Co. Kg product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54875000401. 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 (5-4-1)
54875-0004-1
11-Digit CMS (5-4-2)
54875-0004-01

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