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  5. NDC Package Code: 0078-0435-61 Reclast

NDC Package 0078-0435-61 Reclast

Zoledronic Acid 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:
0078-0435-61
Package Description:
100 mL in 1 BOTTLE
Product Code:
0078-0435
Proprietary Name:
Reclast
Non-Proprietary Name:
Zoledronic Acid
Substance Name:
Zoledronic Acid
Usage Information:
This medication is used to treat a certain type of bone disease (Paget's disease) that causes abnormal and weak bones. Zoledronic acid is also used to treat bone loss (osteoporosis) in men and in women after menopause who are at high risk of having broken bones (fractures). It may also be used to treat or prevent osteoporosis in people who are taking corticosteroid medications (such as prednisone) for long periods. It works by slowing the breakdown of bone and keeping bones strong. It also helps to reduce the risk of broken bones (fractures). This medication belongs to a class of drugs known as bisphosphonates. Another zoledronic acid product is used to treat bone problems that may occur with cancer. The 2 products should not be used together.
11-Digit NDC Billing Format:
00078043561
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
100 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 705824 - zoledronic acid 5 MG in 100 ML Injection
  • RxCUI: 705824 - 100 ML zoledronic acid 0.05 MG/ML Injection
  • RxCUI: 705824 - zoledronic acid 5 MG per 100 ML Injection
  • RxCUI: 705875 - Reclast 5 MG in 100 ML Injection
  • RxCUI: 705875 - 100 ML zoledronic acid 0.05 MG/ML Injection [Reclast]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    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):
  • ZOLEDRONIC ACID 5 mg/100mL
    • Pharmacologic Class(es):
  • Bisphosphonate - [EPC] (Established Pharmacologic Class)
  • Diphosphonates - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA021817
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-01-2007
    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 0078-0435-61 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00078043561J3489Zoledronic acid 1mg1 MG100155

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0078-0435-61?

    The NDC Packaged Code 0078-0435-61 is assigned to a package of 100 ml in 1 bottle of Reclast, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 0078-0435 included in the NDC Directory?

    Yes, Reclast with product code 0078-0435 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on April 01, 2007 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 0078-0435-61?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 0078-0435-61?

    The 11-digit format is 00078043561. 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 4-4-2 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
    4-4-20078-0435-615-4-200078-0435-61