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  5. NDC Package Code: 0078-1000-60 Leqvio

NDC Package 0078-1000-60 Leqvio

Inclisiran Injection, Solution Subcutaneous - 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:
0078-1000-60
Package Description:
1 SYRINGE, GLASS in 1 CARTON / 1.5 mL in 1 SYRINGE, GLASS
Product Code:
0078-1000
Proprietary Name:
Leqvio
Non-Proprietary Name:
Inclisiran
Substance Name:
Inclisiran Sodium
Usage Information:
LEQVIO® is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C).Limitations of UseThe effect of LEQVIO on cardiovascular morbidity and mortality has not been determined.
11-Digit NDC Billing Format:
00078100060
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2588263 - inclisiran 284 MG in 1.5 ML Prefilled Syringe
  • RxCUI: 2588263 - 1.5 ML inclisiran 189 MG/ML Prefilled Syringe
  • RxCUI: 2588263 - inclisiran 284 MG per 1.5 ML Prefilled Syringe
  • RxCUI: 2588269 - LEQVIO 284 MG in 1.5 ML Prefilled Syringe
  • RxCUI: 2588269 - 1.5 ML inclisiran 189 MG/ML Prefilled Syringe [Leqvio]
    • 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):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • INCLISIRAN SODIUM 284 mg/1.5mL
    • Sample Package:
    No
    FDA Application Number:
    NDA214012
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-22-2021
    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 0078-1000-60 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00078100060J1306Injection, inclisiran, 1 mg1 MG1.51284284

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0078-1000-981 SYRINGE, GLASS in 1 CARTON / 1.5 mL in 1 SYRINGE, GLASS

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0078-1000-60?

    The NDC Packaged Code 0078-1000-60 is assigned to a package of 1 syringe, glass in 1 carton / 1.5 ml in 1 syringe, glass of Leqvio, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 0078-1000 included in the NDC Directory?

    Yes, Leqvio with product code 0078-1000 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on December 22, 2021 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 0078-1000-60?

    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 0078-1000-60?

    The 11-digit format is 00078100060. 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
    4-4-20078-1000-605-4-200078-1000-60