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  5. NDC Package Code: 83703-531-02 Palonosetron Hydrochloride

NDC Package 83703-531-02 Palonosetron Hydrochloride

Injection Intravenous - 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:
83703-531-02
Package Description:
1 VIAL in 1 CARTON / 5 mL in 1 VIAL (83703-531-01)
Product Code:
83703-531
Proprietary Name:
Palonosetron Hydrochloride
Non-Proprietary Name:
Palonosetron Hydrochloride
Substance Name:
Palonosetron Hydrochloride
Usage Information:
Palonosetron hydrochloride injection is indicated in adults for prevention of:acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC).postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.Palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of:acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.
11-Digit NDC Billing Format:
83703053102
Product Type:
Human Prescription Drug
Labeler Name:
Bamboo Us Bidco Lcc
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • PALONOSETRON HYDROCHLORIDE .25 mg/5mL
    • 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:
    ANDA206916
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-12-2021
    Listing Expiration Date:
    12-31-2025
    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 83703-531-02?

    The NDC Packaged Code 83703-531-02 is assigned to a package of 1 vial in 1 carton / 5 ml in 1 vial (83703-531-01) of Palonosetron Hydrochloride, a human prescription drug labeled by Bamboo Us Bidco Lcc. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 83703-531 included in the NDC Directory?

    Yes, Palonosetron Hydrochloride with product code 83703-531 is active and included in the NDC Directory. The product was first marketed by Bamboo Us Bidco Lcc on November 12, 2021 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 83703-531-02?

    The 11-digit format is 83703053102. 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
    5-3-283703-531-025-4-283703-0531-02