FDA.reportPublic FDA data

NDC 25682-019-01 - STRENSIQ

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
25682-019
Requested NDC
25682-019-01
Package NDCs from labels
25682-019-01, 25682-019-12
Manufacturer
Alexion Pharmaceuticals, Inc.
Effective date
2025-12-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
STRENSIQ - Alexion Pharmaceuticals, Inc.Alexion Pharmaceuticals, Inc.2025-12-12HUMAN PRESCRIPTION DRUG LABEL

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 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

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

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 24 of 50 · 988 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BIO2 Lactose FreeKALI PHOS, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products3013d3a9-7f20-4d19-e063-6394a90a58142025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Products2ffcffd8-94ba-3a4c-e063-6394a90a24ee2025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO5FERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Products2ffd4d8f-75bf-1b9b-e063-6294a90abc362025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO6FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products2ffd93dd-1084-4b24-e063-6294a90a14332025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO7CALC PHOS, FERR PHOS, KALI PHOS, NAT PHOS, NAT SULPHBestmade Natural Products2ffdc916-b94f-774e-e063-6294a90a9cc82025-03-10WarningsExact identifier
unii: 70WT22SF4B
Bestmade Natural Products BIO11FERR PHOS, KALI MUR, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products2fff2361-a171-2249-e063-6394a90a8b652025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO12FERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Products2fff612e-16dc-dcbf-e063-6294a90a22ad2025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products30002ebe-3b38-cb35-e063-6394a90a8f7e2025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO1CALC PHOS FERR PHOS, KALI PHOS, NAT MURBestmade Natural Products2fd724b6-c6cf-652a-e063-6294a90ab4d72025-03-08WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO2KALI PHOS, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products2fd794c0-a553-e3f5-e063-6294a90a522a2025-03-08WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM253CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products2fa9913f-0593-f77b-e063-6394a90ab6b22025-03-06WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM254APIS MEL, BRYONIA, GELSEMIUM, NAT MUR, PULSATILLABestmade Natural Products2fa9bb2c-848b-06ef-e063-6394a90ad0f02025-03-06WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Nat MurNATRUM MURIATICUMBestmade Natural Products2fa9f3a3-91e3-2f8e-e063-6294a90afda82025-03-06WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Nat PhosNATRUM PHOSPHORICUMBestmade Natural Products2faa1f81-98d7-5cbf-e063-6394a90a33c92025-03-06WarningsExact identifier
unii: 70WT22SF4B
Bestmade Natural Products BM244CALC CARB, CALC PHOS, CARBO VEG, NAT MUR, PHYSOSTIGMA, RUTA GRAV.Bestmade Natural Products2f853410-e831-90ce-e063-6394a90a26b12025-03-04WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM213GRAPHITES, RHUS TOX, NATRUM SULPH, CARBO VEG, NAT PHOSBestmade Natural Products2f6d9587-7185-7fef-e063-6394a90aa6fd2025-03-03WarningsExact identifier
unii: 70WT22SF4B
Bestmade Natural Products BM214CARBO VEG, FERRUM PHOS, SILICA, KALI CARB, CALC PHOS, NAT MURBestmade Natural Products2f6e08d8-a6f9-c049-e063-6394a90a6df12025-03-03WarningsExact identifier
unii: 451W47IQ8X
Adrenal LiquescenceGLYCYRRHIZA GLABRA, ROSA CANINA, ARALIA QUINQUEFOLIA, GLANDULA SUPRARENALIS (BOVINE), ADRENALINUM, CINCHONA OFFICINALIS, NATRUM MURIATICUM, ZINCUM METALLICUM, ADRENOCORTICOTROPHINNutritional Specialties, Inc.5254181b-188e-4ef2-b91e-15e87e31de702025-02-26WarningsExact identifier
unii: 451W47IQ8X
MB CAPSMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEAllegis Pharmaceuticals, LLC2efeb281-b84b-4750-e063-6394a90a27ee2025-02-25Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Bestmade Natural Products BM188ALLIUM CEPA, AMBROSIA ARTEMISIA, GELSEMIUM, KALI BICHROME, NAT MUR, SABADILLABestmade Natural Products2e950192-e5cf-37b4-e063-6394a90a1e9a2025-02-20WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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