FDA.reportPublic FDA data

LEQEMBI

Product NDC
62856-212
11-digit product format
628560212
Labeler code
62856
Product ID
62856-212_81ef20f0-d4f7-4f69-b081-e297224b653f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lecanemab
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eisai Inc.
Application
BLA761269
Marketing category
BLA
Marketing start
2023-01-06
Substance
LECANEMAB
Active strength
100 mg/mL
Pharmacologic classes
Amyloid Beta-directed Antibody Interactions [MoA], Amyloid Beta-directed Antibody [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LEQEMBI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LECANEMAB100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
12PYH0FTU9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2626147Internal RxNorm lookup
2626153Internal RxNorm lookup
2626155Internal RxNorm lookup
2626156Internal RxNorm lookup
2723406Internal RxNorm lookup
2747782Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d1ff786-e577-410a-a273-c4d7d0e4e975Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1c683916-2853-400a-9064-1148aaa35eaeProduct name120240215
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62856-212-01LEQEMBI1 in 1 CARTONINJECTION, SOLUTION122
62856-212-01LEQEMBI2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION222

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62856-212-01ML - Milliliter62856-212ec8f8474-7890-48fe-9dd3-078f4a7bf6ba12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62856-212LEQEMBI (LECANEMAB) INJECTION, SOLUTION [EISAI INC.]13Current NDC, Legacy NDC, 2 package rows20250201_9d1ff786-e577-410a-a273-c4d7d0e4e975.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEQEMBILECANEMABEisai Inc.9d1ff786-e577-410a-a273-c4d7d0e4e9752026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761269
ndc (product): 62856-212

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761269Leqembilecanemab-irmb351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2626147lecanemab-irmb 200 MG in 2 ML InjectionPSN9d1ff786-e577-410a-a273-c4d7d0e4e97522
2723406lecanemab-irmb 360 MG in 1.8 ML Auto-InjectorPSN9d1ff786-e577-410a-a273-c4d7d0e4e97522
2626155lecanemab-irmb 500 MG in 5 ML InjectionPSN9d1ff786-e577-410a-a273-c4d7d0e4e97522
2626153LEQEMBI 200 MG in 2 ML InjectionPSN9d1ff786-e577-410a-a273-c4d7d0e4e97522
2626156LEQEMBI 500 MG in 5 ML InjectionPSN9d1ff786-e577-410a-a273-c4d7d0e4e97522
26261532 ML lecanemab-irmb 100 MG/ML Injection [Leqembi]SBD9d1ff786-e577-410a-a273-c4d7d0e4e97522
26261565 ML lecanemab-irmb 100 MG/ML Injection [Leqembi]SBD9d1ff786-e577-410a-a273-c4d7d0e4e97522
27234061.8 ML lecanemab-irmb 200 MG/ML Auto-InjectorSCD9d1ff786-e577-410a-a273-c4d7d0e4e97522
26261472 ML lecanemab-irmb 100 MG/ML InjectionSCD9d1ff786-e577-410a-a273-c4d7d0e4e97522
26261555 ML lecanemab-irmb 100 MG/ML InjectionSCD9d1ff786-e577-410a-a273-c4d7d0e4e97522
26261532 ML Leqembi 100 MG/ML InjectionSY9d1ff786-e577-410a-a273-c4d7d0e4e97522
26261565 ML Leqembi 100 MG/ML InjectionSY9d1ff786-e577-410a-a273-c4d7d0e4e97522
2626147lecanemab-irmb 200 MG per 2 ML InjectionSY9d1ff786-e577-410a-a273-c4d7d0e4e97522
2723406lecanemab-irmb 360 MG per 1.8 ML Auto-InjectorSY9d1ff786-e577-410a-a273-c4d7d0e4e97522
2626155lecanemab-irmb 500 MG per 5 ML InjectionSY9d1ff786-e577-410a-a273-c4d7d0e4e97522
2626153Leqembi 200 MG per 2 ML InjectionSY9d1ff786-e577-410a-a273-c4d7d0e4e97522
2626156Leqembi 500 MG per 5 ML InjectionSY9d1ff786-e577-410a-a273-c4d7d0e4e97522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62856-212-01628560212011 VIAL, SINGLE-DOSE in 1 CARTON (62856-212-01) / 2 mL in 1 VIAL, SINGLE-DOSE2023-01-060000-00-00NoNoCurrent