FDA.reportPublic FDA data

Strensiq 40 MG per 1 ML Injection

RxCUI
1720276
RxNorm name
Strensiq 40 MG per 1 ML Injection
Display name
Strensiq 40 MG per 1 ML Injection
Full name
Strensiq 40 MG per 1 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:53

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125513Strensiqasfotase alfa351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
rxcui: 1720276

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3387574f-5eaa-4501-a71d-4cbfbd563031Strensiq 40 MG in 1 ML Injection [PSN] · 1 ML asfotase alfa 40 MG/ML Injection [Strensiq] [SBD] · 1 ML Strensiq 40 MG/ML Injection [SY] · Strensiq 40 MG per 1 ML Injection [SY]418These 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: 201520251212