Istodax
NDC Package 46026-983-01

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.

Istodax is romidepsin is used to treat certain types of cancer (cutaneous or peripheral T-cell lymphoma). Marketed by Gloucester Pharmaceuticals, Inc., this product is identified by NDC 46026-983 and is authorized under FDA application NDA022393.

Identification & Billing

NDC Package Code
46026-983-01
Package Description
1 KIT in 1 CARTON * 2 mL in 1 VIAL, GLASS (46026-961-10) * 2 mL in 1 VIAL, GLASS (46026-972-02)
Product Code
46026-983
11-Digit Billing Format
46026098301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Istodax
Dosage Form
-
Usage Information
Romidepsin is used to treat certain types of cancer (cutaneous or peripheral T-cell lymphoma). Romidepsin works by stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Gloucester Pharmaceuticals, Inc.
FDA Application #
NDA022393
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-05-2009
End Marketing Date
05-28-2010
Listing Expiration
05-28-2010
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 46026-983-01 identifies a specific commercial package of 1 kit in 1 carton * 2 ml in 1 vial, glass (46026-961-10) * 2 ml in 1 vial, glass (46026-972-02) of Istodax, labeled by Gloucester Pharmaceuticals, Inc.. 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 Gloucester Pharmaceuticals, Inc. on November 05, 2009. The current certification is valid through May 28, 2010.

What are the primary indications for this medication?

Romidepsin is used to treat certain types of cancer (cutaneous or peripheral T-cell lymphoma). Romidepsin works by stopping the growth of cancer cells.

How is this Gloucester Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46026098301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
46026-983-01
11-Digit CMS (5-4-2)
46026-0983-01

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