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  5. NDC Package Code: 35356-197-65 Ondansetron

NDC Package 35356-197-65 Ondansetron

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
35356-197-65
Package Description:
30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code:
35356-197
Proprietary Name:
Ondansetron
Usage Information:
INDICATIONS AND USAGE1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2.2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron orally disintegrating tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.
11-Digit NDC Billing Format:
35356019765
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
Labeler Name:
Quality Care Products Llc
Sample Package:
No
FDA Application Number:
ANDA077557
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
11-10-2010
End Marketing Date:
06-30-2025
Listing Expiration Date:
06-30-2025
Exclude Flag:
D
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 35356-197-65?

The NDC Packaged Code 35356-197-65 is assigned to a package of 30 tablet, orally disintegrating in 1 blister pack of Ondansetron, labeled by Quality Care Products Llc. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

Is NDC 35356-197 included in the NDC Directory?

No, Ondansetron with product code 35356-197 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Quality Care Products Llc on November 10, 2010 and its listing in the NDC Directory is set to expire on June 30, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 35356-197-65?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

What is the 11-digit format for NDC 35356-197-65?

The 11-digit format is 35356019765. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-235356-197-655-4-235356-0197-65