Oxaliplatin
NDC Package 41616-178-40

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.

Oxaliplatin is a medication used to treat advanced cancer of the colon and rectum. Marketed by Sun Pharma Global Inc., this product is identified by NDC 41616-178 and is authorized under FDA application ANDA078818.

Identification & Billing

NDC Package Code
41616-178-40
Package Description
20 mL in 1 VIAL
Product Code
41616-178
11-Digit Billing Format
41616017840
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Oxaliplatin
Dosage Form
-
Usage Information
This medication is used to treat advanced cancer of the colon and rectum. Oxaliplatin is a chemotherapy drug that contains platinum. It is used to slow or stop cancer cell growth.

Regulatory & Marketing

Labeler Name
Sun Pharma Global Inc.
FDA Application #
ANDA078818
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-19-2009
End Marketing Date
12-21-2016
Listing Expiration
12-21-2016
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 41616-178-40 identifies a specific commercial package of 20 ml in 1 vial of Oxaliplatin, labeled by Sun Pharma Global Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Inc. on August 19, 2009. The current certification is valid through December 21, 2016.

What are the primary indications for this medication?

This medication is used to treat advanced cancer of the colon and rectum. Oxaliplatin is a chemotherapy drug that contains platinum. It is used to slow or stop cancer cell growth.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41616017840. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
41616-178-40
11-Digit CMS (5-4-2)
41616-0178-40

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