Temozolomide
NDC Package 58181-4331-4

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.

Temozolomide is a medication used to treat certain types of brain cancer. Marketed by Nextsource Biotechnology Llc, this product is identified by NDC 58181-4331 and is authorized under FDA application ANDA203898.

Identification & Billing

NDC Package Code
58181-4331-4
Package Description
14 POUCH in 1 CARTON / 1 CAPSULE in 1 POUCH
Product Code
58181-4331
11-Digit Billing Format
58181433104

Clinical Specifications

Proprietary Name
Temozolomide
Dosage Form
-
Usage Information
This medication is used to treat certain types of brain cancer. Temozolomide belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Nextsource Biotechnology Llc
FDA Application #
ANDA203898
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2025
End Marketing Date
07-08-2025
Listing Expiration
07-08-2025
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 58181-4331-4 identifies a specific commercial package of 14 pouch in 1 carton / 1 capsule in 1 pouch of Temozolomide, labeled by Nextsource Biotechnology 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 Nextsource Biotechnology Llc on April 01, 2025. The current certification is valid through July 08, 2025.

What are the primary indications for this medication?

This medication is used to treat certain types of brain cancer. Temozolomide belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.

How is this Nextsource Biotechnology Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58181433104. 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)
58181-4331-4
11-Digit CMS (5-4-2)
58181-4331-04

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