Leqembi Injection, Solution
NDC Package 62856-212-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Leqembi (lecanemab) injection is lEQEMBI is indicated for the treatment of Alzheimer’s disease. This formulation utilizes a injection, solution delivery system. Marketed by Eisai Inc., this product is identified by NDC 62856-212 and is authorized under FDA application BLA761269.

Identification & Billing

NDC Package Code
62856-212-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE
Product Code
62856-212
11-Digit Billing Format
62856021201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Leqembi
Non-Proprietary Name
Lecanemab
Substance Name
Lecanemab
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
LECANEMAB 100 mg/mL
Pharmacologic Class
Usage Information
LEQEMBI is indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with LEQEMBI [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

Regulatory & Marketing

Labeler Name
Eisai Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761269
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-06-2023
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

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.

J0174
Source: ASP
Inj, lecanemab-irmb, 1 mg
HCPCS Dosage 1 MG
Units / Pkg 200

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62856-212-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose of Leqembi, a human prescription drug labeled by Eisai Inc.. This injection, solution is formulated for intravenous use and contains lecanemab 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 Eisai Inc. on January 06, 2023. The current certification is valid through December 31, 2027.

How is this Eisai Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62856021201. 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:

10-Digit Format (5-3-2)
62856-212-01
11-Digit CMS (5-4-2)
62856-0212-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.