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  5. NDC Package Code: 42658-021-02 Daunorubicin Hydrochloride

NDC Package 42658-021-02 Daunorubicin Hydrochloride

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

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. 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:
42658-021-02
Package Description:
10 VIAL in 1 CARTON / 4 mL in 1 VIAL
Product Code:
42658-021
Proprietary Name:
Daunorubicin Hydrochloride
Non-Proprietary Name:
Daunorubicin Hydrochloride
Substance Name:
Daunorubicin Hydrochloride
Usage Information:
Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
11-Digit NDC Billing Format:
42658002102
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2002002 - DAUNOrubicin 50 MG in 10 ML Injection
  • RxCUI: 2002002 - 10 ML daunorubicin 5 MG/ML Injection
  • RxCUI: 2002002 - daunorubicin (as daunorubicin hydrochloride 5.34 MG) 50 MG per 10 ML Injection
  • RxCUI: 309650 - DAUNOrubicin HCl 20 MG in 4 ML Injection
  • RxCUI: 309650 - 4 ML daunorubicin 5 MG/ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hisun Pharmaceuticals 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.
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • DAUNORUBICIN HYDROCHLORIDE 5 mg/mL
  • DAUNORUBICIN HYDROCHLORIDE 5 mg/mL
    • Pharmacologic Class(es):
  • Anthracycline Topoisomerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Anthracyclines - [CS]
  • Topoisomerase Inhibitors - [MoA] (Mechanism of Action)
  • Anthracycline Topoisomerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Anthracyclines - [CS]
  • Topoisomerase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA208759
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-20-2020
    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 42658-021-02 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    42658002102J9150Daunorubicin injection10 MG410220

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    42658-021-011 VIAL in 1 BOX / 4 mL in 1 VIAL
    42658-021-911 VIAL in 1 BOX / 4 mL in 1 VIAL
    42658-021-9210 VIAL in 1 CARTON / 4 mL in 1 VIAL

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 42658-021-02?

    The NDC Packaged Code 42658-021-02 is assigned to a package of 10 vial in 1 carton / 4 ml in 1 vial of Daunorubicin Hydrochloride, a human prescription drug labeled by Hisun Pharmaceuticals Usa, Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 42658-021 included in the NDC Directory?

    Yes, Daunorubicin Hydrochloride with product code 42658-021 is active and included in the NDC Directory. The product was first marketed by Hisun Pharmaceuticals Usa, Inc. on January 20, 2020 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 42658-021-02?

    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 42658-021-02?

    The 11-digit format is 42658002102. 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
    5-3-242658-021-025-4-242658-0021-02