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  5. NDC Package Code: 50683-0465-1 Thiotepa

NDC Package 50683-0465-1 Thiotepa

Powder - View Billable Units, 11-Digit Format, RxNorm

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.

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:
50683-0465-1
Package Description:
25 kg in 1 DRUM
Product Code:
50683-0465
Non-Proprietary Name:
Thiotepa
Substance Name:
Thiotepa
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.
11-Digit NDC Billing Format:
50683046501
Product Type:
Bulk Ingredient
Labeler Name:
American Pacific Corporation
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 kg/kg
Sample Package:
N/A
Marketing Category:
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date:
01-13-2020
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Unfinished Product:
Yes
Code Structure:

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.

Frequently Asked Questions

What is NDC 50683-0465-1?

The NDC Packaged Code 50683-0465-1 is assigned to an UNFINISHED drug package of 25 kg in 1 drum of Thiotepa, a bulk ingredient labeled by American Pacific Corporation. The product's dosage form is powder and is administered via form.

Is NDC 50683-0465 included in the NDC Directory?

Yes, Thiotepa is an UNFINISHED PRODUCT with code 50683-0465 that is active and included in the NDC Directory. The product was first marketed by American Pacific Corporation on January 13, 2020 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 50683-0465-1?

The 11-digit format is 50683046501. 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 5-4-1 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-150683-0465-15-4-250683-0465-01