FDA.reportPublic FDA data

11 ML ravulizumab-cwvz 100 MG/ML Injection [Ultomiris]

RxCUI
2461136
RxNorm name
11 ML ravulizumab-cwvz 100 MG/ML Injection [Ultomiris]
Display name
11 ML ravulizumab-cwvz 100 MG/ML Injection [Ultomiris]
Full name
11 ML ravulizumab-cwvz 100 MG/ML Injection [Ultomiris]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:14

Purple Book Biologic Products#

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

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
rxcui: 2461136

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
a9a590d9-0217-43c7-908d-e62a7127979111 ML ravulizumab-cwvz 100 MG/ML Injection [Ultomiris]SBD19These highlights do not include all the information needed to use ULTOMIRIS safely and effectively. See full prescribing information for ULTOMIRIS. ULTOMIRIS ® (ravulizumab-cwvz) injection, for intravenous use Initial U.S. Approval: 201820251009
a9a590d9-0217-43c7-908d-e62a71279791Ultomiris 1100 MG per 11 ML InjectionSY19These highlights do not include all the information needed to use ULTOMIRIS safely and effectively. See full prescribing information for ULTOMIRIS. ULTOMIRIS ® (ravulizumab-cwvz) injection, for intravenous use Initial U.S. Approval: 201820251009
a9a590d9-0217-43c7-908d-e62a71279791Ultomiris 100 MG/ML per 11 ML InjectionSY19These highlights do not include all the information needed to use ULTOMIRIS safely and effectively. See full prescribing information for ULTOMIRIS. ULTOMIRIS ® (ravulizumab-cwvz) injection, for intravenous use Initial U.S. Approval: 201820251009
a9a590d9-0217-43c7-908d-e62a71279791ULTOMIRIS 1100 MG in 11 ML InjectionPSN19These highlights do not include all the information needed to use ULTOMIRIS safely and effectively. See full prescribing information for ULTOMIRIS. ULTOMIRIS ® (ravulizumab-cwvz) injection, for intravenous use Initial U.S. Approval: 201820251009