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 30 of 50 · 988 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Base Laboratories SalineSODIUM CHLORIDEJoonem LLCba0868f6-d3de-40e2-bcb3-144fa53062c72024-12-23WarningsExact identifier
unii: 451W47IQ8X
Base Laboratories SalineSODIUM CHLORIDEJoonem LLC9d83f477-ebbc-4248-8445-769178181d4f2024-12-23WarningsExact identifier
unii: 451W47IQ8X
Trace Mineral CordARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,Energique, Inc.902dd68d-5ce1-481e-8938-6487dcc68dfc2024-12-19WarningsExact identifier
unii: 451W47IQ8X
unii: 70WT22SF4B
Ancient Secrets Breathe AgainSODIUM CHLORIDELOTUS BRANDS, INC.c6d2bab0-d363-4c09-a71b-ae15db915b372024-12-18WarningsExact identifier
unii: 451W47IQ8X
Walgreens Saline Mist Extra StrengthSODIUM CHLORIDEWalgreen's Corporation90cbe2dc-36b6-77fb-e053-2995a90a28972024-12-18WarningsExact identifier
unii: 451W47IQ8X
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy6f1fe980-ca09-401d-aed6-d3d3387cc49a2024-12-18WarningsExact identifier
unii: 451W47IQ8X
Pedia-LaxSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.f001a37d-8ed4-428b-af12-d6a83c22c1272024-12-12WarningsExact identifier
unii: 70WT22SF4B
Mast Cell ProHYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM,Energique, Inc.5cd31e1d-0312-48d1-9ecd-d01c6fe3b6722024-12-11WarningsExact identifier
unii: 451W47IQ8X
Junior MovesANACARDIUM, BRYONIA, MAG MUR, NAT MUR, PLUMB METSilver Star Brands822d5481-7854-3fe7-e053-2a91aa0abf552024-12-03WarningsExact identifier
unii: 451W47IQ8X
Migo-EaseACONITUM NAP, LYCOPODIUM, NAT MUR, NUX VOM, PULSATILLASilver Star Brands816837f5-4487-657d-e053-2991aa0a78f42024-12-03WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company464c2d78-5c88-4668-a039-56dd3c1c9b202024-12-03Exact identifier
unii: 451W47IQ8X
XX Health ProLACHESIS, NAT MUR, PULSATILLA, SEPIA, SULPHURSilver Star Brands4d11a65e-696a-0727-e054-00144ff88e882024-12-02WarningsExact identifier
unii: 451W47IQ8X
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d41602-9dcb-eaa8-e063-6394a90a7cfa2024-11-26WarningsExact identifier
unii: 451W47IQ8X
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d4ddaf-9c07-a7fc-e063-6394a90adc0b2024-11-26WarningsExact identifier
unii: 451W47IQ8X
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d5997b-1cae-41c2-e063-6394a90ac74a2024-11-26WarningsExact identifier
unii: 451W47IQ8X
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation37063a49-6b45-4167-875d-49c9dac3f79b2024-11-20WarningsExact identifier
unii: 451W47IQ8X
ReliefSODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATELeosons Overseas Corp5b301d5b-1e2c-47ed-a05f-d6be0fdfc9402024-11-19WarningsExact identifier
unii: 70WT22SF4B
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company99a15716-bbb9-4e33-a48d-20c58b81f3922024-11-13Exact identifier
unii: 451W47IQ8X
Itch FormulaANTIPYRINUM, APIS MELLIFICA, CALENDULA OFFICINALIS, CANTHARIS, COPAIVA OFFICINALIS, CROTON TIGLIUM, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, MEZEREUM, NATRUM MURIATICUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, SULPHUR, URTICA URENSDeseret Biologicals, Inc.4dfb177b-bff3-4b6d-8fd9-cadd1df7812c2024-11-12WarningsExact identifier
unii: 451W47IQ8X
Plasma-Lyte 148 (pH 7.4)SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDEBaxter Healthcare Corporationfe935c8d-f42d-42e4-8665-0dc66829f2312024-11-08Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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