TAKHZYRO
These highlights do not include all the information needed to use TAKHZYRO safely and effectively. See full prescribing information for TAKHZYRO. TAKHZYRO (lanadelumab-flyo) injection, for subcutaneous useInitial U.S. Approval: 2018
Approved
Approval ID
15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2023
Manufacturers
FDA
Takeda Pharmaceuticals America, Inc.
DUNS: 039997266
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lanadelumab-flyo
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47783-645
Application NumberBLA761090
Product Classification
M
Marketing Category
C73585
G
Generic Name
lanadelumab-flyo
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 8, 2023
FDA Product Classification
INGREDIENTS (6)
lanadelumabActive
Quantity: 150 mg in 1 mL
Code: 2372V1TKXK
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 5.3 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
HISTIDINEInactive
Quantity: 7.8 mg in 1 mL
Code: 4QD397987E
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 4.1 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 5.3 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
lanadelumab-flyo
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47783-646
Application NumberBLA761090
Product Classification
M
Marketing Category
C73585
G
Generic Name
lanadelumab-flyo
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 8, 2023
FDA Product Classification
INGREDIENTS (6)
lanadelumabActive
Quantity: 300 mg in 2 mL
Code: 2372V1TKXK
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 10.6 mg in 2 mL
Code: 94255I6E2T
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 8.2 mg in 2 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 10.6 mg in 2 mL
Code: 451W47IQ8X
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.2 mg in 2 mL
Code: 6OZP39ZG8H
Classification: IACT
HISTIDINEInactive
Quantity: 15.6 mg in 2 mL
Code: 4QD397987E
Classification: IACT
lanadelumab-flyo
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47783-644
Application NumberBLA761090
Product Classification
M
Marketing Category
C73585
G
Generic Name
lanadelumab-flyo
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 8, 2023
FDA Product Classification
INGREDIENTS (6)
lanadelumabActive
Quantity: 300 mg in 2 mL
Code: 2372V1TKXK
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT