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  5. NDC Package Code: 45963-615-56 Topotecan Hydrochloride

NDC Package 45963-615-56 Topotecan Hydrochloride

Injection, Powder, Lyophilized, For 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:
45963-615-56
Package Description:
1 VIAL in 1 CARTON / 4 mL in 1 VIAL
Product Code:
45963-615
Proprietary Name:
Topotecan Hydrochloride
Non-Proprietary Name:
Topotecan Hydrochloride
Substance Name:
Topotecan Hydrochloride
Usage Information:
Topotecan hydrochloride is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan.
11-Digit NDC Billing Format:
45963061556
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1799416 - topotecan 4 MG Injection
  • RxCUI: 1799416 - topotecan (as topotecan hydrochloride) 4 MG Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Actavis Pharma, Inc.
    Dosage Form:
    Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • TOPOTECAN HYDROCHLORIDE 4 mg/4mL
    • Pharmacologic Class(es):
  • Topoisomerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Topoisomerase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA090620
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-05-2015
    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 45963-615-56 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    45963061556J9351Topotecan injection0.1 MG114040

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 45963-615-56?

    The NDC Packaged Code 45963-615-56 is assigned to a package of 1 vial in 1 carton / 4 ml in 1 vial of Topotecan Hydrochloride, a human prescription drug labeled by Actavis Pharma, Inc.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 45963-615 included in the NDC Directory?

    Yes, Topotecan Hydrochloride with product code 45963-615 is active and included in the NDC Directory. The product was first marketed by Actavis Pharma, Inc. on January 05, 2015 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 45963-615-56?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 45963-615-56?

    The 11-digit format is 45963061556. 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
    5-3-245963-615-565-4-245963-0615-56