Irinotecan Hydrochloride
NDC Package 47335-937-40

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.

Irinotecan Hydrochloride is a . Marketed by Sun Pharma Global Fze, this product is identified by NDC 47335-937 and is authorized under FDA application ANDA078805.

Identification & Billing

NDC Package Code
47335-937-40
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE
Product Code
47335-937
11-Digit Billing Format
47335093740

Clinical Specifications

Proprietary Name
Irinotecan Hydrochloride
Dosage Form
-

Regulatory & Marketing

Labeler Name
Sun Pharma Global Fze
FDA Application #
ANDA078805
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-21-2008
End Marketing Date
01-24-2017
Listing Expiration
01-24-2017
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 47335-937-40 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose of Irinotecan Hydrochloride, labeled by Sun Pharma Global Fze. 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 Sun Pharma Global Fze on April 21, 2008. The current certification is valid through January 24, 2017.

How is this Sun Pharma Global Fze product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47335093740. 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)
47335-937-40
11-Digit CMS (5-4-2)
47335-0937-40

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