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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ECULIZUMAB300 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA3ULP0F556
Rxcui700384, 700387

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
25682-001-012021-02-01C16284748780-1ba0f9c33-3126-a910-e053-dadaa90a0b85These 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
25682-001-012021-01-29C16284748780-1ba0f9c33-3126-a910-e053-dadaa90a0b85These 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

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