Ondansetron Hydrochloride Injection
NDC Package 83270-161-01

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

Package Information

Ondansetron Hydrochloride injection is click here to enter Indications. This formulation utilizes a injection delivery system. Marketed by Onesource Specialty Pharma Limited, this product is identified by NDC 83270-161 and is authorized under FDA application ANDA078257.

Identification & Billing

NDC Package Code
83270-161-01
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 20 mL in 1 VIAL, MULTI-DOSE
Product Code
83270-161
11-Digit Billing Format
83270016101
RxNorm Crosswalk
  • RxCUI: 283504 - ondansetron 2 MG/ML Injectable Solution
  • RxCUI: 283504 - ondansetron (as ondansetron HCl ) 2 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Ondansetron Hydrochloride
Non-Proprietary Name
Ondansetron Hydrochloride
Substance Name
Ondansetron Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ONDANSETRON HYDROCHLORIDE 2 mg/mL
Pharmacologic Class
Usage Information
Click here to enter Indications

Regulatory & Marketing

Labeler Name
Onesource Specialty Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA078257
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-30-2023
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 83270-161-01 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 20 ml in 1 vial, multi-dose of Ondansetron Hydrochloride, a human prescription drug labeled by Onesource Specialty Pharma Limited. This injection is formulated for intramuscular; intravenous use and contains ondansetron hydrochloride 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 Onesource Specialty Pharma Limited on September 30, 2023. The current certification is valid through December 31, 2026.

How is this Onesource Specialty Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83270016101. 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)
83270-161-01
11-Digit CMS (5-4-2)
83270-0161-01

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