FDA.reportPublic FDA data

STRENSIQ

Product NDC
25682-019
Requested package NDC
25682-019-12
11-digit product format
256820019
Labeler code
25682
Product ID
25682-019_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
80 mg/.8mL
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 ALFA80 mg/.8mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z633861EIMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1720263Internal RxNorm lookup
1720268Internal RxNorm lookup
1720271Internal RxNorm lookup
1720272Internal RxNorm lookup
1720275Internal RxNorm lookup
1720276Internal RxNorm lookup
1720278Internal RxNorm lookup
1720280Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3387574f-5eaa-4501-a71d-4cbfbd563031Available on FDA.report

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
25682-019-01STRENSIQ0.8 mL in 1 VIALSOLUTION0.818
25682-019-12STRENSIQ12 in 1 CARTONSOLUTION1218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25682-019-01ML - Milliliter25682-0195f9e82a3-5b1e-4ca9-a0b9-6d83aceb7bc112015-12-02
25682-019-12ML - Milliliter25682-019bb6623af-cb02-4949-9cc0-a4f080250a0a12015-11-12

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
25682-019STRENSIQ (ASFOTASE ALFA) SOLUTION [ALEXION PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 2 package rows20240719_3387574f-5eaa-4501-a71d-4cbfbd563031.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STRENSIQASFOTASE ALFAAlexion Pharmaceuticals, Inc.3387574f-5eaa-4501-a71d-4cbfbd5630312025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125513
ndc (package): 25682-019-12
ndc (product): 25682-019
ndc11 (package): 25682001912

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125513Strensiqasfotase alfa351(a)Rx2026-06-01

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
25682-019-122568200191212 VIAL in 1 CARTON (25682-019-12) / .8 mL in 1 VIAL (25682-019-01) 12 vial2015-10-230000-00-00NoNoCurrent