Ondansetron Solution
NDC Package 17856-0672-2

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

Package Information

Ondansetron (ondansetron hydrochloride) solution is ondansetron oral solution is indicated for the prevention of nausea and vomiting associated with:highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2initial and repeat courses of moderately emetogenic cancer chemotherapyradiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomenOndansetron oral solution is also indicated for the prevention of postoperative nausea and/or vomiting. This formulation utilizes a solution delivery system. Marketed by Atlantic Biologics Corp., this product is identified by NDC 17856-0672 and is authorized under FDA application ANDA078776.

Identification & Billing

NDC Package Code
17856-0672-2
Package Description
120 SYRINGE in 1 CASE / 2.5 mL in 1 SYRINGE
Product Code
17856-0672
11-Digit Billing Format
17856067202
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ondansetron
Non-Proprietary Name
Ondansetron Hydrochloride
Substance Name
Ondansetron Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ONDANSETRON HYDROCHLORIDE 4 mg/5mL
Pharmacologic Class
Usage Information
Ondansetron oral solution is indicated for the prevention of nausea and vomiting associated with:highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2initial and repeat courses of moderately emetogenic cancer chemotherapyradiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomenOndansetron oral solution is also indicated for the prevention of postoperative nausea and/or vomiting.

Regulatory & Marketing

Labeler Name
Atlantic Biologics Corp.
Product Type
Human Prescription Drug
FDA Application #
ANDA078776
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-28-2007
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (17856-0672). Click a package code to view its specific billing and regulatory data.

17856-0672-1
60 SYRINGE in 1 CASE / 2.5 mL in 1 SYRINGE
17856-0672-3
120 SYRINGE in 1 CASE / 2.5 mL in 1 SYRINGE
17856-0672-4
72 CUP, UNIT-DOSE in 1 CASE / 5 mL in 1 CUP, UNIT-DOSE

* 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 17856-0672-2 identifies a specific commercial package of 120 syringe in 1 case / 2.5 ml in 1 syringe of Ondansetron, a human prescription drug labeled by Atlantic Biologics Corp.. This solution is formulated for oral 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 Atlantic Biologics Corp. on November 28, 2007. The current certification is valid through December 31, 2026.

How is this Atlantic Biologics Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856067202. 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 (5-4-1)
17856-0672-2
11-Digit CMS (5-4-2)
17856-0672-02

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