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NDC 62856-0215-01 LEQEMBI 100 mg/mL Details
LEQEMBI 100 mg/mL
LEQEMBI is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eisai Inc.. The primary component is LECANEMAB.
Product Information
NDC | 62856-0215 |
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Product ID | 62856-215_f440b027-4ced-429a-970a-4ab7600c617d |
Associated GPIs | |
GCN Sequence Number | 084287 |
GCN Sequence Number Description | lecanemab-irmb VIAL 500 MG/5ML INTRAVEN |
HIC3 | H1H |
HIC3 Description | AMYLOID DIRECTED MONOCLONAL ANTIBODY |
GCN | 53524 |
HICL Sequence Number | 048590 |
HICL Sequence Number Description | LECANEMAB-IRMB |
Brand/Generic | Brand |
Proprietary Name | LEQEMBI |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | lecanemab |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, SOLUTION |
Route | INTRAVENOUS |
Active Ingredient Strength | 100 |
Active Ingredient Units | mg/mL |
Substance Name | LECANEMAB |
Labeler Name | Eisai Inc. |
Pharmaceutical Class | Amyloid Beta-directed Antibody Interactions [MoA], Amyloid Beta-directed Antibody [EPC] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA761269 |
Listing Certified Through | 2024-12-31 |
Package
NDC 62856-0215-01 (62856021501)
NDC Package Code | 62856-215-01 |
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Billing NDC | 62856021501 |
Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (62856-215-01) / 5 mL in 1 VIAL, SINGLE-DOSE |
Marketing Start Date | 2023-01-06 |
NDC Exclude Flag | N |
Pricing Information | N/A |