leqembi

Generic: lecanemab

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

Drug Facts

Product Profile

Brand Name leqembi
Generic Name lecanemab
Labeler eisai inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

lecanemab 100 mg/mL

Manufacturer
Eisai Inc.

Identifiers & Regulatory

Product NDC 62856-212
Product ID 62856-212_81ef20f0-d4f7-4f69-b081-e297224b653f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761269
Listing Expiration 2027-12-31
Marketing Start 2023-01-06

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 62856212
Hyphenated Format 62856-212

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 leqembi (source: ndc)
Generic Name lecanemab (source: ndc)
Application Number BLA761269 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (62856-212-01) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

62856-212-01 1 VIAL, SINGLE-DOSE in 1 CARTON (62856-212-01) / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

lecanemab (100 mg/mL)

Linked Drug Pages (1)

LEQEMBI, LECANEMAB AUTOINJECTOR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "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 VIAL, SINGLE-DOSE in 1 CARTON (62856-212-01)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "62856-212-01", "marketing_start_date": "20230106"}], "brand_name": "LEQEMBI", "product_id": "62856-212_81ef20f0-d4f7-4f69-b081-e297224b653f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amyloid Beta-directed Antibody Interactions [MoA]", "Amyloid Beta-directed Antibody [EPC]"], "product_ndc": "62856-212", "generic_name": "lecanemab", "labeler_name": "Eisai Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEQEMBI", "active_ingredients": [{"name": "LECANEMAB", "strength": "100 mg/mL"}], "application_number": "BLA761269", "marketing_category": "BLA", "marketing_start_date": "20230106", "listing_expiration_date": "20271231"}