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 Identifiers#

Field, Values table
FieldValues
Unii12PYH0FTU9
Rxcui2626147, 2626153, 2626155, 2626156, 2723406

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

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