Gleostine Capsule, Gelatin Coated
NDC Package 58181-3041-5

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Gleostine (lomustine) capsules is a medication used to treat various types of cancer. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Nextsource Biotechnology, Llc, this product is identified by NDC 58181-3041 and is authorized under FDA application NDA017588.

Identification & Billing

NDC Package Code
58181-3041-5
Package Description
1 BOTTLE in 1 CARTON / 5 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
58181-3041
11-Digit Billing Format
58181304105
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gleostine
Non-Proprietary Name
Lomustine
Substance Name
Lomustine
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LOMUSTINE 40 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat various types of cancer. Lomustine 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
Product Type
Human Prescription Drug
FDA Application #
NDA017588
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-18-2014
Listing Expiration
12-31-2026
Exclude Flag
N
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 58181-3041-5 identifies a specific commercial package of 1 bottle in 1 carton / 5 capsule, gelatin coated in 1 bottle of Gleostine, a human prescription drug labeled by Nextsource Biotechnology, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This capsule, gelatin coated is formulated for oral use and contains lomustine 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 Nextsource Biotechnology, Llc on August 18, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat various types of cancer. Lomustine 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: 58181304105. 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 (5-4-1)
58181-3041-5
11-Digit CMS (5-4-2)
58181-3041-05

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