1. Home
  2. Labeler Index
  3. Natco Pharma Limited
  4. 63850-0003
  5. NDC Package Code: 63850-0003-1 Ondansetron

NDC Package 63850-0003-1 Ondansetron

Ondansetron Tablets Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
63850-0003-1
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
63850-0003
Proprietary Name:
Ondansetron
Non-Proprietary Name:
Ondansetron Tablets
Substance Name:
Ondansetron Hydrochloride
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/m2. initial 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 tablets are also indicated for the prevention of postoperative nausea and/or vomiting.
11-Digit NDC Billing Format:
63850000301
NDC to RxNorm Crosswalk:
  • RxCUI: 198052 - ondansetron HCl 4 MG Oral Tablet
  • RxCUI: 198052 - ondansetron 4 MG Oral Tablet
  • RxCUI: 198052 - ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet
  • RxCUI: 312086 - ondansetron HCl 8 MG Oral Tablet
  • RxCUI: 312086 - ondansetron 8 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Natco Pharma Limited
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ONDANSETRON HYDROCHLORIDE 4 mg/1
    • Pharmacologic Class(es):
  • Serotonin 3 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Serotonin-3 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA077851
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-25-2007
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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 63850-0003-1?

    The NDC Packaged Code 63850-0003-1 is assigned to a package of 30 tablet, film coated in 1 bottle of Ondansetron, a human prescription drug labeled by Natco Pharma Limited. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 63850-0003 included in the NDC Directory?

    Yes, Ondansetron with product code 63850-0003 is active and included in the NDC Directory. The product was first marketed by Natco Pharma Limited on June 25, 2007 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 63850-0003-1?

    The 11-digit format is 63850000301. 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 5-4-1 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
    5-4-163850-0003-15-4-263850-0003-01