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  4. NDC Product Code: 16590-545 Ondansetron

NDC 16590-545 Ondansetron

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 16590-545?
  5. Ondansetron Uses
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
16590-545
Proprietary Name:
Ondansetron
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Stat Rx Usa
Labeler Code:
16590
Product Label ID:
5e2dbda9-aceb-4bfb-9c3f-e7b6118f580c
Start Marketing Date: [9]
10-27-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
7 MM
Imprint(s):
G;4
Score:
1
Flavor(s):
STRAWBERRY (C73417)

Code Structure Chart

Product Details

What is NDC 16590-545?

The NDC code 16590-545 is assigned by the FDA to the product Ondansetron which is product labeled by Stat Rx Usa. The product's dosage form is . The product is distributed in a single package with assigned NDC code 16590-545-30 30 tablet, orally disintegrating in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Ondansetron?

INDICATIONS AND USAGEPrevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 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. 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 hydrochloride tablets and ondansetron orally disintegrating tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.

Which are Ondansetron UNII Codes?

The UNII codes for the active ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Ondansetron?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 104894 - ondansetron 4 MG Disintegrating Oral Tablet
  • RxCUI: 104894 - ondansetron (as ondansetron HCl) 4 MG Disintegrating Oral Tablet

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".