lecanemab autoinjector

Generic: lecanemab-irmb

Labeler: eisai inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name lecanemab autoinjector
Generic Name lecanemab-irmb
Labeler eisai inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

lecanemab-irmb 200 mg/mL

Manufacturer
Eisai Inc.

Identifiers & Regulatory

Product NDC 62856-220
Product ID 62856-220_81ef20f0-d4f7-4f69-b081-e297224b653f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761375
Listing Expiration 2027-12-31
Marketing Start 2025-08-29

Pharmacologic Class

Established (EPC)
amyloid beta-directed antibody [epc]
Mechanism of Action
amyloid beta-directed antibody interactions [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62856220
Hyphenated Format 62856-220

Supplemental Identifiers

RxCUI
2626147 2626153 2626155 2626156 2723406
UNII
12PYH0FTU9
NUI
N0000193951 N0000193950

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lecanemab autoinjector (source: ndc)
Generic Name lecanemab-irmb (source: ndc)
Application Number BLA761375 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, PLASTIC in 1 CARTON (62856-220-01) / 1.8 mL in 1 SYRINGE, PLASTIC (62856-220-10)
source: ndc

Packages (1)

Ingredients (1)

lecanemab-irmb (200 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["SUBCUTANEOUS"], "spl_id": "81ef20f0-d4f7-4f69-b081-e297224b653f", "openfda": {"nui": ["N0000193951", "N0000193950"], "unii": ["12PYH0FTU9"], "rxcui": ["2626147", "2626153", "2626155", "2626156", "2723406"], "spl_set_id": ["9d1ff786-e577-410a-a273-c4d7d0e4e975"], "pharm_class_epc": ["Amyloid Beta-directed Antibody [EPC]"], "pharm_class_moa": ["Amyloid Beta-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Eisai Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, PLASTIC in 1 CARTON (62856-220-01)  / 1.8 mL in 1 SYRINGE, PLASTIC (62856-220-10)", "package_ndc": "62856-220-01", "marketing_start_date": "20250829"}], "brand_name": "LECANEMAB AUTOINJECTOR", "product_id": "62856-220_81ef20f0-d4f7-4f69-b081-e297224b653f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amyloid Beta-directed Antibody Interactions [MoA]", "Amyloid Beta-directed Antibody [EPC]"], "product_ndc": "62856-220", "generic_name": "lecanemab-irmb", "labeler_name": "Eisai Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LECANEMAB AUTOINJECTOR", "active_ingredients": [{"name": "LECANEMAB-IRMB", "strength": "200 mg/mL"}], "application_number": "BLA761375", "marketing_category": "BLA", "marketing_start_date": "20250829", "listing_expiration_date": "20271231"}