FDA.reportPublic FDA data

Ultomiris

Product NDC
25682-022
11-digit product format
256820022
Labeler code
25682
Product ID
25682-022_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
2018-12-21
Substance
RAVULIZUMAB
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
Ultomiris
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RAVULIZUMAB300 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC3VX249T6L
Rxcui2107320, 2107325, 2461134, 2461136, 2461139, 2461140

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
25682-022-01Ultomiris30 mL in 1 VIAL, GLASSSOLUTION, CONCENTRATE3019
25682-022-01Ultomiris1 in 1 CARTONSOLUTION, CONCENTRATE119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25682-022-01ML - Milliliter25682-0223447cdc1-d856-445d-8946-5e586a53437912019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25682-022ULTOMIRIS (RAVULIZUMAB) SOLUTION, CONCENTRATE [ALEXION PHARMACEUTICALS INC.]18Current NDC, Legacy NDC, 2 package rows20240927_a9a590d9-0217-43c7-908d-e62a71279791.zip

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
25682-022-01256820022011 VIAL, GLASS in 1 CARTON (25682-022-01) / 30 mL in 1 VIAL, GLASS2018-12-210000-00-00NoNoCurrent