TAKHZYRO
- Product NDC
- 47783-645
- 11-digit product format
- 477830645
- Labeler code
- 47783
- Product ID
- 47783-645_143e1cd2-1b4f-4b78-bdbf-7ac83300e34c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lanadelumab-flyo
- Dosage form
- SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- BLA761090
- Marketing category
- BLA
- Marketing start
- 2023-02-03
- Substance
- LANADELUMAB
- Active strength
- 150 mg/mL
- Pharmacologic classes
- Kallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2372V1TKXK | LANADELUMAB | 1426055-14-2 | LANADELUMAB |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 47783-645-01 | 47783064501 | 1 SYRINGE, GLASS in 1 CARTON (47783-645-01) / 1 mL in 1 SYRINGE, GLASS | 2023-02-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TAKHZYRO | Takeda Pharmaceuticals America, Inc. | 2025-02-28 | HUMAN PRESCRIPTION DRUG LABEL | 14 |