FDA.reportPublic FDA data

Ultomiris

Product NDC
25682-025
11-digit product format
256820025
Labeler code
25682
Product ID
25682-025_41262953-a849-4095-b9c2-5a1d8b0238cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ravulizumab
Dosage form
SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Alexion Pharmaceuticals Inc.
Application
BLA761108
Marketing category
BLA
Marketing start
2020-10-09
Substance
RAVULIZUMAB
Active strength
300 mg/3mL
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
Ultomiris
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RAVULIZUMAB300 mg/3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C3VX249T6LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2107320Internal RxNorm lookup
2107325Internal RxNorm lookup
2461134Internal RxNorm lookup
2461136Internal RxNorm lookup
2461139Internal RxNorm lookup
2461140Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a9a590d9-0217-43c7-908d-e62a71279791Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
82335218-f3f2-4826-a45d-e6cd00a3321cProduct name320230322

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25682-025-01Ultomiris1 in 1 CARTONSOLUTION, CONCENTRATE119
25682-025-01Ultomiris3 mL in 1 VIAL, GLASSSOLUTION, CONCENTRATE319

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25682-025ULTOMIRIS (RAVULIZUMAB) SOLUTION, CONCENTRATE [ALEXION PHARMACEUTICALS INC.]18Current NDC, Legacy NDC, 2 package rows20240927_a9a590d9-0217-43c7-908d-e62a71279791.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
UltomirisRAVULIZUMABAlexion Pharmaceuticals Inc.a9a590d9-0217-43c7-908d-e62a712797912025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761108
ndc (product): 25682-025

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761108Ultomirisravulizumab-cwvz351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2461134ravulizumab-cwvz 1100 MG in 11 ML InjectionPSNa9a590d9-0217-43c7-908d-e62a7127979119
2461139ravulizumab-cwvz 300 MG in 3 ML InjectionPSNa9a590d9-0217-43c7-908d-e62a7127979119
2107320ravulizumab-cwvz 300 MG in 30 ML InjectionPSNa9a590d9-0217-43c7-908d-e62a7127979119
2461136ULTOMIRIS 1100 MG in 11 ML InjectionPSNa9a590d9-0217-43c7-908d-e62a7127979119
2461140ULTOMIRIS 300 MG in 3 ML InjectionPSNa9a590d9-0217-43c7-908d-e62a7127979119
2107325ULTOMIRIS 300 MG in 30 ML InjectionPSNa9a590d9-0217-43c7-908d-e62a7127979119
246113611 ML ravulizumab-cwvz 100 MG/ML Injection [Ultomiris]SBDa9a590d9-0217-43c7-908d-e62a7127979119
24611403 ML ravulizumab-cwvz 100 MG/ML Injection [Ultomiris]SBDa9a590d9-0217-43c7-908d-e62a7127979119
210732530 ML ravulizumab-cwvz 10 MG/ML Injection [Ultomiris]SBDa9a590d9-0217-43c7-908d-e62a7127979119
246113411 ML ravulizumab-cwvz 100 MG/ML InjectionSCDa9a590d9-0217-43c7-908d-e62a7127979119
24611393 ML ravulizumab-cwvz 100 MG/ML InjectionSCDa9a590d9-0217-43c7-908d-e62a7127979119
210732030 ML ravulizumab-cwvz 10 MG/ML InjectionSCDa9a590d9-0217-43c7-908d-e62a7127979119
210732530 ML Ultomiris 10 MG/ML InjectionSYa9a590d9-0217-43c7-908d-e62a7127979119
2461134ravulizumab-cwvz 100 MG/ML per 11 ML InjectionSYa9a590d9-0217-43c7-908d-e62a7127979119
2461139ravulizumab-cwvz 100 MG/ML per 3 ML InjectionSYa9a590d9-0217-43c7-908d-e62a7127979119
2461134ravulizumab-cwvz 1100 MG per 11 ML InjectionSYa9a590d9-0217-43c7-908d-e62a7127979119
2461139ravulizumab-cwvz 300 MG per 3 ML InjectionSYa9a590d9-0217-43c7-908d-e62a7127979119
2107320ravulizumab-cwvz 300 MG per 30 ML InjectionSYa9a590d9-0217-43c7-908d-e62a7127979119
2461136Ultomiris 100 MG/ML per 11 ML InjectionSYa9a590d9-0217-43c7-908d-e62a7127979119
2461140Ultomiris 100 MG/ML per 3 ML InjectionSYa9a590d9-0217-43c7-908d-e62a7127979119
2461136Ultomiris 1100 MG per 11 ML InjectionSYa9a590d9-0217-43c7-908d-e62a7127979119
2107325Ultomiris 300 MG in 30 ML InjectionSYa9a590d9-0217-43c7-908d-e62a7127979119
2461140Ultomiris 300 MG per 3 ML InjectionSYa9a590d9-0217-43c7-908d-e62a7127979119

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
25682-025-01256820025011 VIAL, GLASS in 1 CARTON (25682-025-01) / 3 mL in 1 VIAL, GLASS2020-10-090000-00-00NoNoCurrent