Oxaliplatin Injection, Solution, Concentrate
NDC Package 0955-1733-20

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Oxaliplatin injection is a medication used to treat advanced cancer of the colon and rectum. This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc, this product is identified by NDC 0955-1733 and is authorized under FDA application NDA021759.

Identification & Billing

NDC Package Code
0955-1733-20
Package Description
1 VIAL, GLASS in 1 CARTON / 20 mL in 1 VIAL, GLASS
Product Code
0955-1733
11-Digit Billing Format
00955173320
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
Non-Proprietary Name
Oxaliplatin
Substance Name
Oxaliplatin
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
OXALIPLATIN 5 mg/mL
Pharmacologic Class
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
Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021759
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
09-01-2015
Listing Expiration
12-31-2026
Exclude Flag
N
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 0955-1733-20 identifies a specific commercial package of 1 vial, glass in 1 carton / 20 ml in 1 vial, glass of Oxaliplatin, a human prescription drug labeled by Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc. This injection, solution, concentrate is formulated for intravenous use and contains oxaliplatin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc on September 01, 2015. The current certification is valid through December 31, 2026.

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 Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00955173320. 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 (4-4-2)
0955-1733-20
11-Digit CMS (5-4-2)
00955-1733-20

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