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  5. NDC Package Code: 69543-371-10 Palonosetron Hydrochloride

NDC Package 69543-371-10 Palonosetron 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:
69543-371-10
Package Description:
10 CARTON in 1 BOX / 1 VIAL in 1 CARTON (69543-371-01) / 5 mL in 1 VIAL
Product Code:
69543-371
Proprietary Name:
Palonosetron Hydrochloride
Non-Proprietary Name:
Palonosetron Hydrochloride
Substance Name:
Palonosetron Hydrochloride
Usage Information:
Palonosetron Hydrochloride is contraindicated in patients known to have hypersensitivity to the drug or any of its components [see Adverse Reactions (6.2)].
11-Digit NDC Billing Format:
69543037110
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:
    Virtus Pharmaceuticals, Llc
    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:
    ANDA209287
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-19-2018
    End Marketing Date:
    01-31-2026
    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 69543-371-10 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    69543037110J2469Palonosetron hcl25 MCG51010100

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69543-371-10?

    The NDC Packaged Code 69543-371-10 is assigned to a package of 10 carton in 1 box / 1 vial in 1 carton (69543-371-01) / 5 ml in 1 vial of Palonosetron Hydrochloride, a human prescription drug labeled by Virtus Pharmaceuticals, Llc. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 69543-371 included in the NDC Directory?

    Yes, Palonosetron Hydrochloride with product code 69543-371 is active and included in the NDC Directory. The product was first marketed by Virtus Pharmaceuticals, Llc on September 19, 2018.

    What is the NDC billing unit for package 69543-371-10?

    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 69543-371-10?

    The 11-digit format is 69543037110. 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
    5-3-269543-371-105-4-269543-0371-10