Leqvio Injection, Solution
NDC Package 0078-1000-60
Package Information
Leqvio (inclisiran) injection is 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. This formulation utilizes a injection, solution delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-1000 and is authorized under FDA application NDA214012.
Identification & Billing
- 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]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0078 - Novartis Pharmaceuticals Corporation
- 0078-1000 - Leqvio
- 0078-1000-60 - 1 SYRINGE, GLASS in 1 CARTON / 1.5 mL in 1 SYRINGE, GLASS
- 0078-1000 - Leqvio
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.
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Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* Please review the full disclaimer at the bottom of this page.
Other Available Packages
The following commercial packages are registered under the same Product NDC (0078-1000). Click a package code to view its specific billing and regulatory data.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0078-1000-60 identifies a specific commercial 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. This injection, solution is formulated for subcutaneous use and contains inclisiran sodium as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Novartis Pharmaceuticals Corporation on December 22, 2021. The current certification is valid through December 31, 2027.
How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078100060. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.
