FDA.reportPublic FDA data

5 ML Brineura 30 MG/ML Injection

RxCUI
1922458
RxNorm name
5 ML Brineura 30 MG/ML Injection
Display name
5 ML Brineura 30 MG/ML Injection
Full name
5 ML Brineura 30 MG/ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761052Brineuracerliponase alfa351(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
BrineuraCERLIPONASE ALFABioMarin Pharmaceutical Inc.485ab3c5-0359-4878-872f-2fe1e7df40472024-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1922458

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
485ab3c5-0359-4878-872f-2fe1e7df40475 ML Brineura 30 MG/ML InjectionSY30These highlights do not include all the information needed to use BRINEURA safely and effectively. See full prescribing information for BRINEURA. BRINEURA (cerliponase alfa) injection, for intraventricular use Initial U.S. Approval: 201720240805
485ab3c5-0359-4878-872f-2fe1e7df4047Brineura 150 MG per 5 ML Intraventricular InjectionSY30These highlights do not include all the information needed to use BRINEURA safely and effectively. See full prescribing information for BRINEURA. BRINEURA (cerliponase alfa) injection, for intraventricular use Initial U.S. Approval: 201720240805
485ab3c5-0359-4878-872f-2fe1e7df40475 ML cerliponase alfa 30 MG/ML Injection [Brineura]SBD30These highlights do not include all the information needed to use BRINEURA safely and effectively. See full prescribing information for BRINEURA. BRINEURA (cerliponase alfa) injection, for intraventricular use Initial U.S. Approval: 201720240805
485ab3c5-0359-4878-872f-2fe1e7df4047Brineura 150 MG in 5 mL Intraventricular InjectionPSN30These highlights do not include all the information needed to use BRINEURA safely and effectively. See full prescribing information for BRINEURA. BRINEURA (cerliponase alfa) injection, for intraventricular use Initial U.S. Approval: 201720240805