Ondansetron Hydrochloride
NDC Package 36000-013-01

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 discontinued by the firm.

Ondansetron Hydrochloride is ondansetron Injection, USP is contraindicated for patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 36000-013 and is authorized under FDA application ANDA078288.

Identification & Billing

NDC Package Code
36000-013-01
Package Description
1 VIAL in 1 CARTON / 20 mL in 1 VIAL
Product Code
36000-013
11-Digit Billing Format
36000001301
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 Hydrochloride
Dosage Form
-
Usage Information
Ondansetron Injection, USP is contraindicated for patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. Anaphylactic reactions have been reported in patients taking ondansetron. [See Adverse Reactions (6.2)].The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
FDA Application #
ANDA078288
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-13-2013
End Marketing Date
03-09-2020
Listing Expiration
03-09-2020
Exclude Flag
D
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 36000-013-01 identifies a specific commercial package of 1 vial in 1 carton / 20 ml in 1 vial of Ondansetron Hydrochloride, labeled by Baxter Healthcare Corporation. 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 Baxter Healthcare Corporation on March 13, 2013. The current certification is valid through March 09, 2020.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36000001301. 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)
36000-013-01
11-Digit CMS (5-4-2)
36000-0013-01

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