MedPath

STRENSIQ

These highlights do not include all the information needed to use STRENSIQ safely and effectively. See full prescribing information for STRENSIQ. STRENSIQ (asfotase alfa) injection, for subcutaneous use Initial U.S. Approval: 2015

Approved
Approval ID

3387574f-5eaa-4501-a71d-4cbfbd563031

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 14, 2023

Manufacturers
FDA

Alexion Pharmaceuticals, Inc.

DUNS: 789359510

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ASFOTASE ALFA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code25682-010
Application NumberBLA125513
Product Classification
M
Marketing Category
C73585
G
Generic Name
ASFOTASE ALFA
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 14, 2023
FDA Product Classification

INGREDIENTS (4)

ASFOTASE ALFAActive
Quantity: 18 mg in 0.45 mL
Code: Z633861EIM
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Quantity: 2.48 mg in 0.45 mL
Code: 70WT22SF4B
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 0.28 mg in 0.45 mL
Code: 593YOG76RN
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 3.94 mg in 0.45 mL
Code: 451W47IQ8X
Classification: IACT

ASFOTASE ALFA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code25682-016
Application NumberBLA125513
Product Classification
M
Marketing Category
C73585
G
Generic Name
ASFOTASE ALFA
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 14, 2023
FDA Product Classification

INGREDIENTS (4)

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Quantity: 5.5 mg in 1 mL
Code: 70WT22SF4B
Classification: IACT
ASFOTASE ALFAActive
Quantity: 40 mg in 1 mL
Code: Z633861EIM
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 0.62 mg in 1 mL
Code: 593YOG76RN
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.76 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT

ASFOTASE ALFA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code25682-019
Application NumberBLA125513
Product Classification
M
Marketing Category
C73585
G
Generic Name
ASFOTASE ALFA
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 14, 2023
FDA Product Classification

INGREDIENTS (4)

ASFOTASE ALFAActive
Quantity: 80 mg in 0.8 mL
Code: Z633861EIM
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Quantity: 4.4 mg in 0.8 mL
Code: 70WT22SF4B
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 0.5 mg in 0.8 mL
Code: 593YOG76RN
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7.01 mg in 0.8 mL
Code: 451W47IQ8X
Classification: IACT

ASFOTASE ALFA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code25682-013
Application NumberBLA125513
Product Classification
M
Marketing Category
C73585
G
Generic Name
ASFOTASE ALFA
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 14, 2023
FDA Product Classification

INGREDIENTS (4)

ASFOTASE ALFAActive
Quantity: 28 mg in 0.7 mL
Code: Z633861EIM
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Quantity: 3.85 mg in 0.7 mL
Code: 70WT22SF4B
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 0.43 mg in 0.7 mL
Code: 593YOG76RN
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 6.13 mg in 0.7 mL
Code: 451W47IQ8X
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

STRENSIQ - FDA Drug Approval Details