BKEMV
- Product NDC
- 55513-180
- 11-digit product format
- 555130180
- Labeler code
- 55513
- Product ID
- 55513-180_20150720-3435-4d6c-8eb1-55e6bc56cdce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- eculizumab-aeeb
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Amgen Inc
- Application
- BLA761333
- Marketing category
- BLA
- Marketing start
- 2025-03-01
- Substance
- ECULIZUMAB
- Active strength
- 300 mg/30mL
- Pharmacologic classes
- Complement Inhibitor [EPC], Complement Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BKEMV
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ECULIZUMAB | 300 mg/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A3ULP0F556 |
| Rxcui | 2706351, 2706358 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55513-180-01 | BKEMV | 30 mL in 1 VIAL | INJECTION, SOLUTION, CONCENTRATE | 30 | | 7 |
| 55513-180-01 | BKEMV | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55513-180 | BKEMV (ECULIZUMAB-AEEB) INJECTION, SOLUTION, CONCENTRATE [AMGEN INC] | 5 | Current NDC, 2 package rows | 20250302_002f9748-b0e8-4b6e-a38b-56930a839491.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55513-180-01 | 55513018001 | 1 VIAL in 1 CARTON (55513-180-01) / 30 mL in 1 VIAL | 1 vial | 2025-03-01 | No | No | Current |