takhzyro

Generic: lanadelumab-flyo

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name takhzyro
Generic Name lanadelumab-flyo
Labeler takeda pharmaceuticals america, inc.
Dosage Form SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

lanadelumab 150 mg/mL

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 47783-645
Product ID 47783-645_143e1cd2-1b4f-4b78-bdbf-7ac83300e34c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761090
Listing Expiration 2026-12-31
Marketing Start 2023-02-03

Pharmacologic Class

Established (EPC)
plasma kallikrein inhibitor [epc]
Mechanism of Action
kallikrein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47783645
Hyphenated Format 47783-645

Supplemental Identifiers

RxCUI
2055645 2055650 2593416 2593419 2629980 2629981
UNII
2372V1TKXK
NUI
N0000192750 N0000184151

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name takhzyro (source: ndc)
Generic Name lanadelumab-flyo (source: ndc)
Application Number BLA761090 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 150 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (47783-645-01) / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

47783-645-01 1 SYRINGE, GLASS in 1 CARTON (47783-645-01) / 1 mL in 1 SYRINGE, GLASS

Ingredients (1)

lanadelumab (150 mg/mL)

Linked Drug Pages (1)

TAKHZYRO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "143e1cd2-1b4f-4b78-bdbf-7ac83300e34c", "openfda": {"nui": ["N0000192750", "N0000184151"], "unii": ["2372V1TKXK"], "rxcui": ["2055645", "2055650", "2593416", "2593419", "2629980", "2629981"], "spl_set_id": ["15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e8"], "pharm_class_epc": ["Plasma Kallikrein Inhibitor [EPC]"], "pharm_class_moa": ["Kallikrein Inhibitors [MoA]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (47783-645-01)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "47783-645-01", "marketing_start_date": "20230203"}], "brand_name": "TAKHZYRO", "product_id": "47783-645_143e1cd2-1b4f-4b78-bdbf-7ac83300e34c", "dosage_form": "SOLUTION", "pharm_class": ["Kallikrein Inhibitors [MoA]", "Plasma Kallikrein Inhibitor [EPC]"], "product_ndc": "47783-645", "generic_name": "lanadelumab-flyo", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TAKHZYRO", "active_ingredients": [{"name": "LANADELUMAB", "strength": "150 mg/mL"}], "application_number": "BLA761090", "marketing_category": "BLA", "marketing_start_date": "20230203", "listing_expiration_date": "20261231"}