Carmustine Kit
NDC Package 68475-503-01

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

Package Information

Carmustine kits is a medication used to treat certain types of cancer (including multiple myeloma, brain tumor, Hodgkin's disease, non-Hodgkin's lymphoma). This formulation utilizes a kit delivery system. Marketed by Navinta Llc, this product is identified by NDC 68475-503 and is authorized under FDA application ANDA210179.

Identification & Billing

NDC Package Code
68475-503-01
Package Description
1 KIT in 1 CARTON * 3 mL in 1 VIAL (68475-502-01) * 30 mL in 1 VIAL, SINGLE-DOSE (68475-500-01)
Product Code
68475-503
11-Digit Billing Format
68475050301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Carmustine
Non-Proprietary Name
Carmustine
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This medication is used to treat certain types of cancer (including multiple myeloma, brain tumor, Hodgkin's disease, non-Hodgkin's lymphoma). Carmustine 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
Navinta Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA210179
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-29-2020
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 68475-503-01 identifies a specific commercial package of 1 kit in 1 carton * 3 ml in 1 vial (68475-502-01) * 30 ml in 1 vial, single-dose (68475-500-01) of Carmustine, a human prescription drug labeled by Navinta Llc. This kit is formulated for use and contains 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 Navinta Llc on December 29, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain types of cancer (including multiple myeloma, brain tumor, Hodgkin's disease, non-Hodgkin's lymphoma). Carmustine belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.

How is this Navinta Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68475050301. 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)
68475-503-01
11-Digit CMS (5-4-2)
68475-0503-01

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