FASENRA
- Product NDC
- 0310-1745
- 11-digit product format
- 003101745
- Labeler code
- 0310
- Product ID
- 0310-1745_b78fbf2b-888c-41e2-bdab-cb5cd1ebb8fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benralizumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- BLA761070
- Marketing category
- BLA
- Marketing start
- 2024-04-05
- Substance
- BENRALIZUMAB
- Active strength
- 10 mg/.5mL
- Pharmacologic classes
- Interleukin 5 Receptor alpha-directed Antibody Interactions [MoA], Interleukin-5 Receptor alpha-directed Cytolytic Antibody [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 71492GE1FX | BENRALIZUMAB | 1044511-01-4 | BENRALIZUMAB |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0310-1745-01 | 00310174501 | 1 CARTRIDGE in 1 CARTON (0310-1745-01) / .5 mL in 1 CARTRIDGE | 1 cartridge | 2024-06-03 | No | No | Historical |
| 0310-1745-95 | 00310174595 | 1 CARTRIDGE in 1 CARTON (0310-1745-95) / .5 mL in 1 CARTRIDGE | 1 cartridge | 2024-06-03 | Yes | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| FASENRA | AstraZeneca Pharmaceuticals LP | AstraZeneca PLC | AstraZeneca AB | 2026-05-13 | HUMAN PRESCRIPTION DRUG LABEL | 27 |