Hemlibra
- Product NDC
- 50242-927
- 11-digit product format
- 502420927
- Labeler code
- 50242
- Product ID
- 50242-927_8f25ff10-e9d1-46a1-9889-e2c3f6e0d432
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- emicizumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Genentech, Inc.
- Application
- BLA761083
- Marketing category
- BLA
- Marketing start
- 2024-01-31
- Substance
- EMICIZUMAB
- Active strength
- 12 mg/.4mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 50242-927_8f25ff10-e9d1-46a1-9889-e2c3f6e0d432
- SPL ID
- 8f25ff10-e9d1-46a1-9889-e2c3f6e0d432
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Hemlibra
- Generic name
- emicizumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing start
- 2024-01-31
- Marketing category
- BLA
- Application number
- BLA761083
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| EMICIZUMAB | 12 mg/.4mL |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 7NL2E3F6K3 |
| Rxcui | 1989799, 1989804, 1989809, 1989811, 1989814, 1989815, 1989816, 1989817, 2632728, 2632729, 2675567, 2675568 |
| Spl Set Id | 2483adba-fab6-4d1b-96c5-c195577ed071 |
| Manufacturer Name | Genentech, Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 50242-927-01 | 1 VIAL, SINGLE-USE in 1 CARTON (50242-927-01) / .4 mL in 1 VIAL, SINGLE-USE | 2024-01-31 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 7NL2E3F6K3 | EMICIZUMAB | 1610943-06-0 | EMICIZUMAB |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50242-927-01 | 50242092701 | 1 VIAL, SINGLE-USE in 1 CARTON (50242-927-01) / .4 mL in 1 VIAL, SINGLE-USE | 2024-01-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Hemlibra | Genentech, Inc. | F. Hoffmann-La Roche Ltd. | Roche Diagnostics | F. Hoffmann-La Roche AG | 2025-07-11 | HUMAN PRESCRIPTION DRUG LABEL | 17 |