NDC Package 63459-348-04 Bendeka

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

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:
63459-348-04
Package Description:
1 VIAL, MULTI-DOSE in 1 CARTON / 4 mL in 1 VIAL, MULTI-DOSE
Product Code:
Proprietary Name:
Bendeka
Non-Proprietary Name:
Bendamustine Hydrochloride
Substance Name:
Bendamustine Hydrochloride
Usage Information:
This medication is used to treat certain types of cancer. Bendamustine belongs to a class of cancer chemotherapy drugs known as alkylating agents. It works by killing cancer cells or slowing their growth.
11-Digit NDC Billing Format:
63459034804
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1726097 - bendamustine HCl 25 MG/ML Injectable Solution
  • RxCUI: 1726097 - bendamustine hydrochloride 25 MG/ML Injectable Solution
  • RxCUI: 1726102 - BENDEKA 25 MG/ML Injectable Solution
  • RxCUI: 1726102 - bendamustine hydrochloride 25 MG/ML Injectable Solution [Bendeka]
  • RxCUI: 1726102 - Bendeka 25 MG/ML Injectable Solution
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Teva 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.
  • Sample Package:
    No
    FDA Application Number:
    NDA208194
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-08-2015
    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.

    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 63459-348-04 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    63459034804J9034Inj., bendeka 1 mg1 MG41100100

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63459-348-04?

    The NDC Packaged Code 63459-348-04 is assigned to a package of 1 vial, multi-dose in 1 carton / 4 ml in 1 vial, multi-dose of Bendeka, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 63459-348 included in the NDC Directory?

    Yes, Bendeka with product code 63459-348 is active and included in the NDC Directory. The product was first marketed by Teva Pharmaceuticals Usa, Inc. on December 08, 2015 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 NDC billing unit for package 63459-348-04?

    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 63459-348-04?

    The 11-digit format is 63459034804. 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
    5-3-263459-348-045-4-263459-0348-04