Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
STRENSIQ
Product Details
NDC Product Code
25682-010Application Number
BLA125513Marketing Category
BLA (C73585)Route of Administration
SUBCUTANEOUSEffective Date
March 14, 2023Asfotase alfaActive
Code: Z633861EIMClass: ACTIBQuantity: 18 mg in 0.45 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4BClass: IACTQuantity: 2.48 mg in 0.45 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACTQuantity: 0.28 mg in 0.45 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 3.94 mg in 0.45 mL
STRENSIQ
Product Details
NDC Product Code
25682-016Application Number
BLA125513Marketing Category
BLA (C73585)Route of Administration
SUBCUTANEOUSEffective Date
March 14, 2023SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4BClass: IACTQuantity: 5.5 mg in 1 mL
Asfotase alfaActive
Code: Z633861EIMClass: ACTIBQuantity: 40 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACTQuantity: 0.62 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8.76 mg in 1 mL
STRENSIQ
Product Details
NDC Product Code
25682-019Application Number
BLA125513Marketing Category
BLA (C73585)Route of Administration
SUBCUTANEOUSEffective Date
March 14, 2023Asfotase alfaActive
Code: Z633861EIMClass: ACTIBQuantity: 80 mg in 0.8 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4BClass: IACTQuantity: 4.4 mg in 0.8 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACTQuantity: 0.5 mg in 0.8 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7.01 mg in 0.8 mL
STRENSIQ
Product Details
NDC Product Code
25682-013Application Number
BLA125513Marketing Category
BLA (C73585)Route of Administration
SUBCUTANEOUSEffective Date
March 14, 2023Asfotase alfaActive
Code: Z633861EIMClass: ACTIBQuantity: 28 mg in 0.7 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4BClass: IACTQuantity: 3.85 mg in 0.7 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACTQuantity: 0.43 mg in 0.7 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 6.13 mg in 0.7 mL