TAKHZYRO
- Product NDC
- 47783-646
- 11-digit product format
- 477830646
- Labeler code
- 47783
- Product ID
- 47783-646_17d1082c-b049-4d08-a7e9-4625ed80656a
- 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
- 2022-02-08
- Substance
- LANADELUMAB
- Active strength
- 300 mg/2mL
- Pharmacologic classes
- Kallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TAKHZYRO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LANADELUMAB | 300 mg/2mL |
Harmonized UNII identifiers#
UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| 2372V1TKXK | Internal UNII lookup |
Harmonized RxCUI identifiers#
RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| 2055645 | Internal RxNorm lookup |
| 2055650 | Internal RxNorm lookup |
| 2593416 | Internal RxNorm lookup |
| 2593419 | Internal RxNorm lookup |
| 2629980 | Internal RxNorm lookup |
| 2629981 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47783-646-01 | TAKHZYRO | 2 mL in 1 SYRINGE, GLASS | SOLUTION | 2 | | 14 |
| 47783-646-01 | TAKHZYRO | 1 in 1 CARTON | SOLUTION | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47783-646 | TAKHZYRO (LANADELUMAB-FLYO) SOLUTION TAKHZYRO (LANADELUMAB-FLYO) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20250312_15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e8.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761090 | Takhzyro | lanadelumab-flyo | 351(a) | Disc | 2026-10-01 |
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 |
|---|
| 47783-646-01 | 47783064601 | 1 SYRINGE, GLASS in 1 CARTON (47783-646-01) / 2 mL in 1 SYRINGE, GLASS | 2022-02-08 | 0000-00-00 | No | No | Current |