Thiotepa Injection
NDC Package 58621-004-01

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 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 injection is thiotepa is used to treat cancer. This formulation utilizes a injection delivery system. Marketed by Piramal Pharma Solutions Inc., this product is identified by NDC 58621-004.

Identification & Billing

NDC Package Code
58621-004-01
Package Description
15 mg in 1 VIAL
Product Code
58621-004
11-Digit Billing Format
58621000401

Clinical Specifications

Proprietary Name
Thiotepa
Non-Proprietary Name
Thiotepa
Substance Name
Thiotepa
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Active Ingredient(s)
THIOTEPA 15 mg/15mg
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
Piramal Pharma Solutions Inc.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
10-07-2016
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 58621-004-01 identifies a specific commercial package of 15 mg in 1 vial of Thiotepa (UNFINISHED drug), drug for further processing labeled by Piramal Pharma Solutions Inc.. This injection 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 Piramal Pharma Solutions Inc. on October 07, 2016. 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 Piramal Pharma Solutions Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58621000401. 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)
58621-004-01
11-Digit CMS (5-4-2)
58621-0004-01

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