FDA.reportPublic FDA data

STRENSIQ

Product NDC
25682-013
11-digit product format
256820013
Labeler code
25682
Product ID
25682-013_404d99e5-991e-4353-bb9f-29dfa00a43b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ASFOTASE ALFA
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Labeler
Alexion Pharmaceuticals, Inc.
Application
BLA125513
Marketing category
BLA
Marketing start
2015-10-23
Substance
ASFOTASE ALFA
Active strength
28 mg/.7mL
Pharmacologic classes
Alkaline Phosphatase [CS], Tissue-nonspecific Alkaline Phosphatase [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
STRENSIQ
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASFOTASE ALFA28 mg/.7mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ633861EIM
Rxcui1720263, 1720268, 1720271, 1720272, 1720275, 1720276, 1720278, 1720280

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
07226e8b-a352-4e94-8eb5-4de79b615302Product name120151105
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25682-013-01STRENSIQ0.7 mL in 1 VIALSOLUTION0.718
25682-013-12STRENSIQ12 in 1 CARTONSOLUTION1218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25682-013-01ML - Milliliter25682-013e430c4f7-dc07-4c48-81c1-56ef3b9a808612015-12-02
25682-013-12ML - Milliliter25682-0137cc8035e-230b-4be6-88aa-6eb677fc666912015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASFOTASE ALFAACTIVE INGREDIENTZ633861EIMSTRENSIQ (ASFOTASE ALFA) SOLUTION [ALEXION PHARMACEUTICALS INC.]8
ASFOTASE ALFAACTIVE MOIETYZ633861EIMSTRENSIQ (ASFOTASE ALFA) SOLUTION [ALEXION PHARMACEUTICALS INC.]8
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSTRENSIQ (ASFOTASE ALFA) SOLUTION [ALEXION PHARMACEUTICALS INC.]8
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINACTIVE INGREDIENT70WT22SF4BSTRENSIQ (ASFOTASE ALFA) SOLUTION [ALEXION PHARMACEUTICALS INC.]8
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNSTRENSIQ (ASFOTASE ALFA) SOLUTION [ALEXION PHARMACEUTICALS INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25682-013STRENSIQ (ASFOTASE ALFA) SOLUTION [ALEXION PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 2 package rows20240719_3387574f-5eaa-4501-a71d-4cbfbd563031.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1720263asfotase alfa 18 MG in 0.45 ML InjectionPSN3387574f-5eaa-4501-a71d-4cbfbd56303118
1720271asfotase alfa 28 MG in 0.7 ML InjectionPSN3387574f-5eaa-4501-a71d-4cbfbd56303118
1720275asfotase alfa 40 MG in 1 ML InjectionPSN3387574f-5eaa-4501-a71d-4cbfbd56303118
1720278asfotase alfa 80 MG in 0.8 ML InjectionPSN3387574f-5eaa-4501-a71d-4cbfbd56303118
1720268Strensiq 18 MG in 0.45 ML InjectionPSN3387574f-5eaa-4501-a71d-4cbfbd56303118
1720272Strensiq 28 MG in 0.7 ML InjectionPSN3387574f-5eaa-4501-a71d-4cbfbd56303118
1720276Strensiq 40 MG in 1 ML InjectionPSN3387574f-5eaa-4501-a71d-4cbfbd56303118
1720280Strensiq 80 MG in 0.8 ML InjectionPSN3387574f-5eaa-4501-a71d-4cbfbd56303118
17202680.45 ML asfotase alfa 40 MG/ML Injection [Strensiq]SBD3387574f-5eaa-4501-a71d-4cbfbd56303118
17202720.7 ML asfotase alfa 40 MG/ML Injection [Strensiq]SBD3387574f-5eaa-4501-a71d-4cbfbd56303118
17202800.8 ML asfotase alfa 100 MG/ML Injection [Strensiq]SBD3387574f-5eaa-4501-a71d-4cbfbd56303118
17202761 ML asfotase alfa 40 MG/ML Injection [Strensiq]SBD3387574f-5eaa-4501-a71d-4cbfbd56303118
17202630.45 ML asfotase alfa 40 MG/ML InjectionSCD3387574f-5eaa-4501-a71d-4cbfbd56303118
17202710.7 ML asfotase alfa 40 MG/ML InjectionSCD3387574f-5eaa-4501-a71d-4cbfbd56303118
17202780.8 ML asfotase alfa 100 MG/ML InjectionSCD3387574f-5eaa-4501-a71d-4cbfbd56303118
17202751 ML asfotase alfa 40 MG/ML InjectionSCD3387574f-5eaa-4501-a71d-4cbfbd56303118
17202800.8 ML Strensiq 100 MG/ML InjectionSY3387574f-5eaa-4501-a71d-4cbfbd56303118
17202761 ML Strensiq 40 MG/ML InjectionSY3387574f-5eaa-4501-a71d-4cbfbd56303118
1720263asfotase alfa 18 MG per 0.45 ML InjectionSY3387574f-5eaa-4501-a71d-4cbfbd56303118
1720271asfotase alfa 28 MG per 0.7 ML InjectionSY3387574f-5eaa-4501-a71d-4cbfbd56303118
1720275asfotase alfa 40 MG per 1 ML InjectionSY3387574f-5eaa-4501-a71d-4cbfbd56303118
1720278asfotase alfa 80 MG per 0.8 ML InjectionSY3387574f-5eaa-4501-a71d-4cbfbd56303118
1720268Strensiq 18 MG per 0.45 ML InjectionSY3387574f-5eaa-4501-a71d-4cbfbd56303118
1720272Strensiq 28 MG per 0.7 ML InjectionSY3387574f-5eaa-4501-a71d-4cbfbd56303118
1720276Strensiq 40 MG per 1 ML InjectionSY3387574f-5eaa-4501-a71d-4cbfbd56303118
1720280Strensiq 80 MG per 0.8 ML InjectionSY3387574f-5eaa-4501-a71d-4cbfbd56303118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25682-013-01256820013010.7 mL in 1 VIAL0.7 mlHistorical
25682-013-122568200131212 VIAL in 1 CARTON (25682-013-12) / .7 mL in 1 VIAL (25682-013-01) 12 vial2015-10-230000-00-00NoNoCurrent