FDA.reportPublic FDA data

Brineura

Product NDC
68135-811
11-digit product format
681350811
Labeler code
68135
Product ID
68135-811_1ebeb049-90ec-42ff-9361-b6fa38d79515
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cerliponase alfa
Dosage form
KIT
Labeler
BioMarin Pharmaceutical Inc.
Application
BLA761052
Marketing category
BLA
Marketing start
2017-04-27
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Brineura
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1922453Internal RxNorm lookup
1922458Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
485ab3c5-0359-4878-872f-2fe1e7df4047Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e24cd0b2-f64d-4b27-8384-dd391529b8e4Product name120170706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68135-500-00Brineura5 mL in 1 VIAL, GLASSINJECTION, SOLUTION10 mL150 mg in 5mL30
68135-811-02Brineura1 in 1 CARTONKIT130

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68135-811-02EA - Each68135-81156714eea-dde9-4f51-872d-45e605ee989b12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68135-811BRINEURA (CERLIPONASE ALFA) KIT [BIOMARIN PHARMACEUTICAL INC.]30Current NDC, Legacy NDC, 2 package rows20240808_485ab3c5-0359-4878-872f-2fe1e7df4047.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
BrineuraCERLIPONASE ALFABioMarin Pharmaceutical Inc.485ab3c5-0359-4878-872f-2fe1e7df40472024-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761052
ndc (product): 68135-811

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761052Brineuracerliponase alfa351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1922458Brineura 150 MG in 5 mL Intraventricular InjectionPSN485ab3c5-0359-4878-872f-2fe1e7df404730
1922453cerliponase alfa 150 MG in 5 mL Intraventricular InjectionPSN485ab3c5-0359-4878-872f-2fe1e7df404730
19224585 ML cerliponase alfa 30 MG/ML Injection [Brineura]SBD485ab3c5-0359-4878-872f-2fe1e7df404730
19224535 ML cerliponase alfa 30 MG/ML InjectionSCD485ab3c5-0359-4878-872f-2fe1e7df404730
19224585 ML Brineura 30 MG/ML InjectionSY485ab3c5-0359-4878-872f-2fe1e7df404730
1922458Brineura 150 MG per 5 ML Intraventricular InjectionSY485ab3c5-0359-4878-872f-2fe1e7df404730
1922453cerliponase alfa 150 MG per 5 ML Intraventricular InjectionSY485ab3c5-0359-4878-872f-2fe1e7df404730

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68135-500-00681350500005 mL in 1 VIAL, GLASS5 mlHistorical
68135-811-02681350811021 KIT in 1 CARTON (68135-811-02) * 5 mL in 1 VIAL, GLASS (68135-500-00) * 5 mL in 1 VIAL, GLASS (68135-495-04) 1 kit2017-04-270000-00-00NoNoCurrent