CRYSVITA
These highlights do not include all the information needed to use CRYSVITA safely and effectively. See full prescribing information for CRYSVITA. CRYSVITA (burosumab-twza) injection, for subcutaneous use Initial U.S. Approval: 2018
Approved
Approval ID
102f96a0-6e3a-4fc1-b204-34d604683af6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2023
Manufacturers
FDA
Kyowa Kirin, Inc.
DUNS: 014778321
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Burosumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42747-304
Application NumberBLA761068
Product Classification
M
Marketing Category
C73585
G
Generic Name
Burosumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 17, 2023
FDA Product Classification
INGREDIENTS (6)
POLYSORBATE 80Inactive
Quantity: 0.50 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
METHIONINEInactive
Quantity: 1.49 mg in 1 mL
Code: AE28F7PNPL
Classification: IACT
SORBITOLInactive
Quantity: 45.91 mg in 1 mL
Code: 506T60A25R
Classification: IACT
HISTIDINEInactive
Quantity: 1.55 mg in 1 mL
Code: 4QD397987E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BUROSUMABActive
Quantity: 30 mg in 1 mL
Code: G9WJT6RD29
Classification: ACTIB
Burosumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42747-203
Application NumberBLA761068
Product Classification
M
Marketing Category
C73585
G
Generic Name
Burosumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 17, 2023
FDA Product Classification
INGREDIENTS (6)
SORBITOLInactive
Quantity: 45.91 mg in 1 mL
Code: 506T60A25R
Classification: IACT
HISTIDINEInactive
Quantity: 1.55 mg in 1 mL
Code: 4QD397987E
Classification: IACT
METHIONINEInactive
Quantity: 1.49 mg in 1 mL
Code: AE28F7PNPL
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.50 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BUROSUMABActive
Quantity: 20 mg in 1 mL
Code: G9WJT6RD29
Classification: ACTIB
Burosumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42747-102
Application NumberBLA761068
Product Classification
M
Marketing Category
C73585
G
Generic Name
Burosumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 17, 2023
FDA Product Classification
INGREDIENTS (6)
BUROSUMABActive
Quantity: 10 mg in 1 mL
Code: G9WJT6RD29
Classification: ACTIB
SORBITOLInactive
Quantity: 45.91 mg in 1 mL
Code: 506T60A25R
Classification: IACT
HISTIDINEInactive
Quantity: 1.55 mg in 1 mL
Code: 4QD397987E
Classification: IACT
METHIONINEInactive
Quantity: 1.49 mg in 1 mL
Code: AE28F7PNPL
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.50 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT