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NDC 62856-0212-01 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 | 62856-0212 |
|---|---|
| Product ID | 62856-212_f440b027-4ced-429a-970a-4ab7600c617d |
| Associated GPIs | |
| GCN Sequence Number | 084285 |
| GCN Sequence Number Description | lecanemab-irmb VIAL 200 MG/2ML INTRAVEN |
| HIC3 | H1H |
| HIC3 Description | AMYLOID DIRECTED MONOCLONAL ANTIBODY |
| GCN | 53523 |
| 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 62856-0212-01 (62856021201)
| NDC Package Code | 62856-212-01 |
|---|---|
| Billing NDC | 62856021201 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (62856-212-01) / 2 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2023-01-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |