Prescription drug · BLA
Leqembi (Lecanemab) NDC 62856-215
Lecanemab 100 mg/mL · Injection, Solution · Intravenous · Eisai Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62856-215-01 | 62856021501 | 1 VIAL, SINGLE-DOSE in 1 CARTON (62856-215-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 6, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Leqembi
- Generic name (nonproprietary)
- lecanemab
- Active ingredients
- Lecanemab — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Eisai Inc.NDC labeler code 62856
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761269
- Marketing start
- Listing expires
- Other FDA classes
- Amyloid Beta-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 62856-215_5bf59fb4-34d6-40dd-9061-a74173f14f58SPL ID 5bf59fb4-34d6-40dd-9061-a74173f14f58SPL set ID 9d1ff786-e577-410a-a273-c4d7d0e4e975RxCUI 2626147, 2626153, 2626155, 2626156, 2723406, 2747782UNII 12PYH0FTU9UPC 0362856222105
- Pharmacologic class
- Amyloid Beta-directed Antibody
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N462856021501followed by a unit qualifier and the quantityPackage 62856-0215-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
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. LEQEMBI is an amyloid beta-directed antibody 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. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 62856-215
- What is NDC 62856-215?
- 62856-215 is the product NDC for Leqembi (lecanemab), Lecanemab 100 mg/mL injection, solution, listed with the FDA by Eisai Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Leqembi (Lecanemab).
- What is the active ingredient?
- Lecanemab.
- Who is the labeler?
- Eisai Inc., NDC labeler code 62856. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Leqembi?
- 1 other product NDC are listed under this name. See all Leqembi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Leqembi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Leqembilecanemab | Lecanemab 100 mg/mL | Injection, SolutionIntravenous | Eisai Inc. | 62856-212 | 62856-0212-01 |
Other NDCs under BLA 761269
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Leqembilecanemab | Lecanemab 100 mg/mL | Injection, SolutionIntravenous | Eisai Inc. | 62856-212 |