Ganite
NDC Package 66657-301-05

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 inactivated by the FDA.

Ganite is indicated for the treatment of clearly symptomatic cancer-related hypercalcemia that has not responded to adequate hydration. Marketed by Genta Incorporated, this product is identified by NDC 66657-301 and is authorized under FDA application NDA019961.

Identification & Billing

NDC Package Code
66657-301-05
Package Description
5 VIAL, SINGLE-USE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-USE (66657-301-01)
Product Code
66657-301
11-Digit Billing Format
66657030105
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ganite
Dosage Form
-
Usage Information
Ganite is indicated for the treatment of clearly symptomatic cancer-related hypercalcemia that has not responded to adequate hydration. In general, patients with a serum calcium (corrected for albumin) < 12 mg/dL would not be expected to be symptomatic. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without diuretics). In the treatment of cancer-related hypercalcemia, it is important first to establish adequate hydration, preferably with intravenous saline, in order to increase the renal excretion of calcium and correct dehydration caused by hypercalcemia.

Regulatory & Marketing

Labeler Name
Genta Incorporated
FDA Application #
NDA019961
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-17-2003
Listing Expiration
12-31-2017
Exclude Flag
I
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 66657-301-05 identifies a specific commercial package of 5 vial, single-use in 1 carton / 20 ml in 1 vial, single-use (66657-301-01) of Ganite, labeled by Genta Incorporated. 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 Genta Incorporated on September 17, 2003. The current certification is valid through December 31, 2017.

How is this Genta Incorporated product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66657030105. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
66657-301-05
11-Digit CMS (5-4-2)
66657-0301-05

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