FDA.reportPublic FDA data

SOLIRIS

Product NDC
25682-001
11-digit product format
256820001
Labeler code
25682
Product ID
25682-001_25021c88-95e1-42f0-b895-921526b90642
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ECULIZUMAB
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Alexion Pharmaceuticals Inc.
Application
BLA125166
Marketing category
BLA
Marketing start
2007-04-02
Substance
ECULIZUMAB
Active strength
300 mg/30mL
Pharmacologic classes
Complement Inhibitor [EPC], Complement Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SOLIRIS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ECULIZUMAB300 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
A3ULP0F556Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
700384Internal RxNorm lookup
700387Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd421817-98f6-4a57-87da-64fa00361661Product name120250616
1944fe02-2140-486a-967c-ad54bb2a479aProduct name120171212

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2021-02-01These highlights do not include all the information needed to use SOLIRIS safely and effectively. See full prescribing information for SOLIRIS. SOLIRIS ® (eculizumab) injection, for intravenous use Initial U.S. Approval: 2007
2021-02-01These highlights do not include all the information needed to use SOLIRIS safely and effectively. See full prescribing information for SOLIRIS. SOLIRIS ® (eculizumab) injection, for intravenous use Initial U.S. Approval: 2007
2021-01-29These highlights do not include all the information needed to use SOLIRIS safely and effectively. See full prescribing information for SOLIRIS. SOLIRIS ® (eculizumab) injection, for intravenous use Initial U.S. Approval: 2007
2021-01-29These highlights do not include all the information needed to use SOLIRIS safely and effectively. See full prescribing information for SOLIRIS. SOLIRIS ® (eculizumab) injection, for intravenous use Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25682-001-01SOLIRIS30 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE3042
25682-001-01SOLIRIS1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25682-001-01ML - Milliliter25682-001cd45d664-e7f7-416b-aded-9ef2782c047b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ECULIZUMABACTIVE INGREDIENTA3ULP0F556SOLIRIS (ECULIZUMAB) INJECTION, SOLUTION, CONCENTRATE [ALEXION PHARMACEUTICALS INC.]20
ECULIZUMABACTIVE MOIETYA3ULP0F556SOLIRIS (ECULIZUMAB) INJECTION, SOLUTION, CONCENTRATE [ALEXION PHARMACEUTICALS INC.]20
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSOLIRIS (ECULIZUMAB) INJECTION, SOLUTION, CONCENTRATE [ALEXION PHARMACEUTICALS INC.]20
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSOLIRIS (ECULIZUMAB) INJECTION, SOLUTION, CONCENTRATE [ALEXION PHARMACEUTICALS INC.]20
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74SOLIRIS (ECULIZUMAB) INJECTION, SOLUTION, CONCENTRATE [ALEXION PHARMACEUTICALS INC.]20
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWSOLIRIS (ECULIZUMAB) INJECTION, SOLUTION, CONCENTRATE [ALEXION PHARMACEUTICALS INC.]20
WATERINACTIVE INGREDIENT059QF0KO0RSOLIRIS (ECULIZUMAB) INJECTION, SOLUTION, CONCENTRATE [ALEXION PHARMACEUTICALS INC.]20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25682-001SOLIRIS (ECULIZUMAB) INJECTION, SOLUTION, CONCENTRATE [ALEXION PHARMACEUTICALS INC.]42Current NDC, Legacy NDC, 2 package rows20250311_ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722.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
SOLIRISECULIZUMABAlexion Pharmaceuticals Inc.ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c7222026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125166
ndc (product): 25682-001

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125166Soliriseculizumab351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
700384eculizumab 300 MG in 30 ML InjectionPSNebcd67fa-b4d1-4a22-b33d-ee8bf6b9c72242
700387Soliris 300 MG in 30 ML InjectionPSNebcd67fa-b4d1-4a22-b33d-ee8bf6b9c72242
70038730 ML eculizumab 10 MG/ML Injection [Soliris]SBDebcd67fa-b4d1-4a22-b33d-ee8bf6b9c72242
70038430 ML eculizumab 10 MG/ML InjectionSCDebcd67fa-b4d1-4a22-b33d-ee8bf6b9c72242
70038730 ML Soliris 10 MG/ML InjectionSYebcd67fa-b4d1-4a22-b33d-ee8bf6b9c72242
700384eculizumab 300 MG per 30 ML InjectionSYebcd67fa-b4d1-4a22-b33d-ee8bf6b9c72242
700387Soliris 300 MG per 30 ML InjectionSYebcd67fa-b4d1-4a22-b33d-ee8bf6b9c72242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25682-001-01256820001011 VIAL in 1 CARTON (25682-001-01) / 30 mL in 1 VIAL1 vial2007-04-020000-00-00NoNoCurrent