Lomustine Capsule
NDC Package 80005-116-02

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

Package Information

Lomustine capsules is a medication used to treat various types of cancer. This formulation utilizes a capsule delivery system. Marketed by Carnegie Pharmaceuticals Llc, this product is identified by NDC 80005-116 and is authorized under FDA application ANDA219265.

Identification & Billing

NDC Package Code
80005-116-02
Package Description
5 CAPSULE in 1 BOTTLE
Product Code
80005-116
11-Digit Billing Format
80005011602
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
5 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lomustine
Non-Proprietary Name
Lomustine
Substance Name
Lomustine
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LOMUSTINE 100 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
Carnegie Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA219265
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-10-2025
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 80005-116-02 identifies a specific commercial package of 5 capsule in 1 bottle of Lomustine, a human prescription drug labeled by Carnegie Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 5 billable units per package. This capsule 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 Carnegie Pharmaceuticals Llc on November 10, 2025. 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 Carnegie Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80005011602. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 5 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)
80005-116-02
11-Digit CMS (5-4-2)
80005-0116-02

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