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  5. NDC Package Code: 69097-439-35 Palonosetron Hydrochloride

NDC Package 69097-439-35 Palonosetron Hydrochloride

Palonsetron Hydrochloride Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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:
69097-439-35
Package Description:
1 VIAL, SINGLE-USE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-USE
Product Code:
69097-439
Proprietary Name:
Palonosetron Hydrochloride
Non-Proprietary Name:
Palonsetron 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 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 cancerchemotherapy, including highly emetogenic cancer chemotherapy.
11-Digit NDC Billing Format:
69097043935
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1728055 - palonosetron 0.25 MG in 5 ML Injection
  • RxCUI: 1728055 - 5 ML palonosetron 0.05 MG/ML Injection
  • RxCUI: 1728055 - palonosetron 0.25 MG per 5 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Cipla Usa Inc.
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    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:
    ANDA206396
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-10-2021
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 69097-439-35 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    69097043935J2469Palonosetron hcl25 MCG511010

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69097-439-35?

    The NDC Packaged Code 69097-439-35 is assigned to a package of 1 vial, single-use in 1 carton / 5 ml in 1 vial, single-use of Palonosetron Hydrochloride, a human prescription drug labeled by Cipla Usa Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 69097-439 included in the NDC Directory?

    Yes, Palonosetron Hydrochloride with product code 69097-439 is active and included in the NDC Directory. The product was first marketed by Cipla Usa Inc. on October 10, 2021 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 NDC billing unit for package 69097-439-35?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 69097-439-35?

    The 11-digit format is 69097043935. 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
    5-3-269097-439-355-4-269097-0439-35