Ondansetron Hydrochloride Tablet, Film Coated
NDC Package 55700-627-30

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 Hydrochloride tablets is ondansetron tablets are indicated for the prevention of nausea and vomiting associated with:highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2initial 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 tablets are also indicated for the prevention of postoperative nausea and/or vomiting. This formulation utilizes a tablet, film coated delivery system. Marketed by Quality Care Products Llc, this product is identified by NDC 55700-627 and is authorized under FDA application ANDA078539.

Identification & Billing

NDC Package Code
55700-627-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
55700-627
11-Digit Billing Format
55700062730
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ondansetron Hydrochloride
Non-Proprietary Name
Ondansetron Hydrochloride
Substance Name
Ondansetron Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ONDANSETRON HYDROCHLORIDE 8 mg/1
Pharmacologic Class
Usage Information
Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with:highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2initial 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 tablets are also indicated for the prevention of postoperative nausea and/or vomiting.

Regulatory & Marketing

Labeler Name
Quality Care Products Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA078539
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-18-2018
End Marketing Date
01-31-2028
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 (55700-627). Click a package code to view its specific billing and regulatory data.

55700-627-10
10 TABLET, FILM COATED in 1 BOTTLE
55700-627-12
12 TABLET, FILM COATED in 1 BOTTLE
55700-627-20
20 TABLET, FILM COATED in 1 BOTTLE

* 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 55700-627-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Ondansetron Hydrochloride, a human prescription drug labeled by Quality Care Products Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet, film coated 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 Quality Care Products Llc on May 18, 2018.

How is this Quality Care Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55700062730. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
55700-627-30
11-Digit CMS (5-4-2)
55700-0627-30

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