Thiotepa
NDC Package 54879-014-13

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.

Thiotepa is used to treat cancer. Marketed by Sti Pharma Llc, this product is identified by NDC 54879-014 and is authorized under FDA application ANDA208242.

Identification & Billing

NDC Package Code
54879-014-13
Package Description
15 mg in 1 VIAL, SINGLE-USE
Product Code
54879-014
11-Digit Billing Format
54879001413
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Thiotepa
Dosage Form
-
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
Sti Pharma Llc
FDA Application #
ANDA208242
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-07-2016
End Marketing Date
10-06-2023
Listing Expiration
10-06-2023
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 54879-014-13 identifies a specific commercial package of 15 mg in 1 vial, single-use of Thiotepa, labeled by Sti Pharma Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Sti Pharma Llc on October 07, 2016. The current certification is valid through October 06, 2023.

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 Sti Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54879001413. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
54879-014-13
11-Digit CMS (5-4-2)
54879-0014-13

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