Ondansetron Hydrochloride Solution
NDC Package 62135-555-58

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

Package Information

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 chemotherapy radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen Ondansetron oral solution is also indicated for the prevention of postoperative nausea and/or vomiting. This formulation utilizes a solution delivery system. Marketed by Chartwell Rx, Llc., this product is identified by NDC 62135-555 and is authorized under FDA application ANDA091342.

Identification & Billing

NDC Package Code
62135-555-58
Package Description
50 mL in 1 BOTTLE
Product Code
62135-555
11-Digit Billing Format
62135055558
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
50 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ondansetron Hydrochloride
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 chemotherapy radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen Ondansetron oral solution is also indicated for the prevention of postoperative nausea and/or vomiting.

Regulatory & Marketing

Labeler Name
Chartwell Rx, Llc.
Product Type
Human Prescription Drug
FDA Application #
ANDA091342
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-27-2011
Listing Expiration
12-31-2027
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

Q0162
Source: ASP
Ondansetron oral
HCPCS Dosage 1 MG
Units / Pkg 40

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 (62135-555). Click a package code to view its specific billing and regulatory data.

62135-555-24
2 TRAY in 1 BOX / 10 PACKAGE in 1 TRAY / 5 mL in 1 PACKAGE (62135-555-45)

* 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 62135-555-58 identifies a specific commercial package of 50 ml in 1 bottle of Ondansetron Hydrochloride, a human prescription drug labeled by Chartwell Rx, Llc.. 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 Chartwell Rx, Llc. on January 27, 2011. The current certification is valid through December 31, 2027.

How is this Chartwell Rx, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62135055558. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 50 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)
62135-555-58
11-Digit CMS (5-4-2)
62135-0555-58

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