LEMTRADA
- Product NDC
- 58468-0200
- 11-digit product format
- 584680200
- Labeler code
- 58468
- Product ID
- 58468-0200_e9b870b2-1ea2-433f-991a-721c3cf582b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ALEMTUZUMAB
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Genzyme Corporation
- Application
- BLA103948
- Marketing category
- BLA
- Marketing start
- 2014-11-18
- Substance
- ALEMTUZUMAB
- Active strength
- 12 mg/1.2mL
- Pharmacologic classes
- CD52-directed Antibody Interactions [MoA], CD52-directed Cytolytic Antibody [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LEMTRADA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALEMTUZUMAB | 12 mg/1.2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3A189DH42V |
| Rxcui | 1594658, 1594663 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58468-0200-1 | LEMTRADA | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 26 |
| 58468-0200-1 | LEMTRADA | 1.2 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION, CONCENTRATE | 1.2 | | 26 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ALEMTUZUMAB | ACTIVE INGREDIENT | 3A189DH42V | LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] | 1 | |
| alemtuzumab | ACTIVE MOIETY | 3A189DH42V | LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] | 1 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] | 1 | |
| POTASSIUM CHLORIDE | INACTIVE INGREDIENT | 660YQ98I10 | LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] | 1 | |
| POTASSIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 4J9FJ0HL51 | LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] | 1 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58468-0200 | LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] | 25 | Current NDC, Legacy NDC, 2 package rows | 20240522_6236b0bc-82e9-4447-9a78-f57d94770269.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58468-0200-1 | 58468020001 | 1 VIAL, SINGLE-USE in 1 CARTON (58468-0200-1) / 1.2 mL in 1 VIAL, SINGLE-USE | 2014-11-18 | 0000-00-00 | No | No | Current |