NDC 25682-016-01 - 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: 25682-016
Requested NDC: 25682-016-01
Package NDCs from labels: 25682-016-01, 25682-016-12
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
Label	Manufacturer	Effective date	Type
STRENSIQ - Alexion Pharmaceuticals, Inc.	Alexion Pharmaceuticals, Inc.	2025-12-12	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
25682-016-01	STRENSIQ	1 mL in 1 VIAL	SOLUTION	1		18
25682-016-12	STRENSIQ	12 in 1 CARTON	SOLUTION	12		18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25682-016	STRENSIQ (ASFOTASE ALFA) SOLUTION [ALEXION PHARMACEUTICALS, INC.]	17	Current NDC, Legacy NDC, 2 package rows	20240719_3387574f-5eaa-4501-a71d-4cbfbd563031.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25682-016-01	ML - Milliliter	25682-016	a77f069d-1c10-4d85-a88e-b05d9aab5025	1	2015-12-02
25682-016-12	ML - Milliliter	25682-016	e0a21e3f-36a4-4069-a235-177cb37789b6	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ASFOTASE ALFA	ACTIVE INGREDIENT	Z633861EIM	STRENSIQ (ASFOTASE ALFA) SOLUTION [ALEXION PHARMACEUTICALS INC.]	8
ASFOTASE ALFA	ACTIVE MOIETY	Z633861EIM	STRENSIQ (ASFOTASE ALFA) SOLUTION [ALEXION PHARMACEUTICALS INC.]	8
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	STRENSIQ (ASFOTASE ALFA) SOLUTION [ALEXION PHARMACEUTICALS INC.]	8
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	INACTIVE INGREDIENT	70WT22SF4B	STRENSIQ (ASFOTASE ALFA) SOLUTION [ALEXION PHARMACEUTICALS INC.]	8
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	STRENSIQ (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 46 of 50 · 988 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Melange combination	CALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEA	Seroyal USA	0a071fbf-0075-4479-e054-00144ff8d46c	2021-07-14	Warnings	Exact identifier unii: 451W47IQ8X unii: 70WT22SF4B
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	4a655cde-283f-4ec8-a3d9-5f539c55c204	2021-05-10	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ed8fd0c1-ac42-4267-877e-ceadf3831c90	2021-04-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dr. Talbots Vital 12	CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUC	Talbot's Pharmaceuticals Family Products, LLC	c10bb804-8169-63da-e053-2a95a90a8306	2021-04-28	Warnings	Exact identifier unii: 451W47IQ8X unii: 70WT22SF4B
Dr. Talbots Infant Daily Allergy Relief	ALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUM	Talbot's Pharmaceuticals Family Products, LLC	c0963200-67dd-6349-e053-2a95a90adde1	2021-04-22	Warnings	Exact identifier unii: 451W47IQ8X
CLINIMIX E	LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE	Baxter Healthcare Company	8469d6fb-d6ef-476f-8cc3-0905192de0a8	2021-04-13	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Medical Purchasing Solutions, LLC	c3f8e83c-4fb9-91da-e053-2a95a90abd63	2021-04-12	Adverse reactions	Exact identifier unii: 451W47IQ8X
CVS Health Sterile Saline Mist Live Better	SODIUM CHLORIDE	CVS Pharmacy	ccc3ab8c-b22f-420d-869b-f2a65b8c7180	2021-03-13	Warnings	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	aeaed9cb-b629-4019-88d2-a916179427de	2021-02-19	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
GUNA KIDNEY PLUS	CALCIUM SULFIDE - CHONDRODENDRON TOMENTOSUM ROOT - EQUISETUM HYEMALE - SUS SCROFA PITUITARY GLAND - APIS MELLIFERA - URTICA URENS - SODIUM CHLORIDE - LOBARIA PULMONARIA - HORSE CHESTNUT - BERBERIS VULGARIS FRUIT - SOLIDAGO VIRAGAUREA FLOWERING TOP -	Guna spa	b8dacd94-8da1-4a8d-e053-2995a90acb67	2021-02-04	Warnings	Exact identifier unii: 451W47IQ8X
Candid- Y	ADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.	Newton Laboratories, Inc.	c68c9c20-3a07-16df-e053-2a95a90a0cbc	2021-02-01	Warnings	Exact identifier unii: 70WT22SF4B
Candid-Y	ADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.	Newton Laboratories, Inc.	c68ea9c3-f95c-dbcd-e053-2995a90a9aeb	2021-02-01	Warnings	Exact identifier unii: 70WT22SF4B
Candid-Y	ADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.	Newton Laboratories, Inc.	c6a37dbe-3092-5ecf-e053-2a95a90a7c39	2021-02-01	Warnings	Exact identifier unii: 70WT22SF4B
Natrum Muriaticum	NATRUM MURIATICUM	True Botanica, LLC	b30b2880-28a1-47bd-83e7-da885a7c6f77	2021-01-24	Warnings	Exact identifier unii: 451W47IQ8X
Met-Tox	ARSENICUM ALBUM, AVENA SATIVA,LYCOPODIUM CLAVATUM,NATRUM MURIATICUM,NUX VOMICA,PHYTOLACCA DECANDRARHAMNUS FRANGULA,SOLIDAGO VIRGAUREA,TRIFOLIUM PRATENSE,HEAVY METAL NOSODES	wHITE mANUFACTURING INC DBA MICRO-WEST	e65db4c2-0bc7-4c50-8f18-b36ee004c4f5	2021-01-21	Warnings	Exact identifier unii: 451W47IQ8X
HPZ	ECHINACEA, GELSEMIUM, HYDRASTIS, HYPERICUM, LYCOPODIUM, NAT MUR, NITRICUM AC, RANUNC BULB, RHUS TOX, THUJA OCC	White Manufacturing Inc. DBA Micro-West	dfbb5a35-8dfe-48f4-9177-6cb52fb44090	2021-01-21	Warnings	Exact identifier unii: 451W47IQ8X
Wood	BELLADONNA, BERBER VULG, CARDUUS MAR, CHELIDONIUM MAJ, CHOLESTERINUM, COLOCYNTHIS, KALI CARB, NAT PHOS, NITRICUM AC, NUX VOM, PLATINUM MET, SEPIA	NET Remedies	95b44ad8-8091-420c-bf18-6e071bd6073b	2021-01-19	Warnings	Exact identifier unii: 70WT22SF4B
Metal	ALUMINIA, AMMON CARB, ANACARDIUM, ANTIMON CRUD, HYDRASTIS, IGNATIA, MAG PHOS, NAT MUR, NITRICUM AC, OSMIUM, PARAFFINUM, SENNA, SILICEA, SPONGIA	NET Remedies	f7682a4e-c767-4429-98aa-e8c5ef6560a6	2021-01-19	Warnings	Exact identifier unii: 451W47IQ8X
Para Solve	CALC CARB, CHENOPODIUM ANTH, CINA, CROTON, FILIX MAS, GAMBOCIA, GRANATUM, LYCOPODIUM, MERC CORROS, NAT PHOS, SANTONINUM, SENNA, SPIGELIA ANTH, STANNUM MET, TANACETUM, TEURICUM MAR, ZINGIBER	NET Remedies	a58f6134-67f0-4691-8e9e-a93f48669d6a	2021-01-19	Warnings	Exact identifier unii: 70WT22SF4B
3% Sodium Chloride	3% SODIUM CHLORIDE	Becton Dickinson and Company	a8058593-48af-457a-b0f0-166935c7d10c	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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