Oxaliplatin
NDC Package 47335-047-40

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 inactivated by the FDA.

Oxaliplatin is a medication used to treat advanced cancer of the colon and rectum. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 47335-047 and is authorized under FDA application ANDA202922.

Identification & Billing

NDC Package Code
47335-047-40
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-USE
Product Code
47335-047
11-Digit Billing Format
47335004740
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

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 Pharmaceutical Industries, Inc.
FDA Application #
ANDA202922
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-09-2014
Listing Expiration
12-31-2019
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 47335-047-40 identifies a specific commercial package of 1 vial, single-use in 1 carton / 20 ml in 1 vial, single-use of Oxaliplatin, labeled by Sun Pharmaceutical Industries, 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 Sun Pharmaceutical Industries, Inc. on April 09, 2014. The current certification is valid through December 31, 2019.

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 Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47335004740. 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)
47335-047-40
11-Digit CMS (5-4-2)
47335-0047-40

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