FDA.reportPublic FDA data

Cablivi

Product NDC
58468-0225
11-digit product format
584680225
Labeler code
58468
Product ID
58468-0225_545bfe88-5343-4f25-a107-5b9bcc2e45a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
caplacizumab
Dosage form
KIT
Labeler
Genzyme Corporation
Application
BLA761112
Marketing category
BLA
Marketing start
2019-02-06
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cablivi
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2110616Internal RxNorm lookup
2110618Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2348f06e-8004-4040-832e-e9e86a39f905Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
0a2311d4-4349-43be-ab91-cc8288d42f23Product name120190611
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58468-0225-1Cablivi1 in 1 CARTONKIT118
58468-0227-1Cablivi1 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,1 mL11 mg in 1mL18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-0225-1EA - Each58468-02254d00fa76-0330-4fb8-a19d-f505ee33771112019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58468-0225CABLIVI (CAPLACIZUMAB) KIT [GENZYME CORPORATION]14Current NDC, Legacy NDC, 2 package rows20241108_2348f06e-8004-4040-832e-e9e86a39f905.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
CabliviCAPLACIZUMABGenzyme Corporation2348f06e-8004-4040-832e-e9e86a39f9052026-04-24Warnings, Adverse reactionsExact identifier
application number: BLA761112
ndc (product): 58468-0225

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761112Cablivicaplacizumab-yhdp351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2110618Cablivi 11 MG InjectionPSN2348f06e-8004-4040-832e-e9e86a39f90518
2110616caplacizumab-yhdp 11 MG InjectionPSN2348f06e-8004-4040-832e-e9e86a39f90518
2110618caplacizumab-yhdp 11 MG Injection [Cablivi]SBD2348f06e-8004-4040-832e-e9e86a39f90518
2110616caplacizumab-yhdp 11 MG InjectionSCD2348f06e-8004-4040-832e-e9e86a39f90518
2110618Cablivi 11 MG InjectionSY2348f06e-8004-4040-832e-e9e86a39f90518

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58468-0225-1584680225011 KIT in 1 CARTON (58468-0225-1) * 1 mL in 1 VIAL, GLASS (58468-0227-1) * 1 mL in 1 SYRINGE, GLASS (58468-0229-1) 1 kit2019-02-060000-00-00NoNoCurrent
58468-0227-1584680227011 mL in 1 VIAL, GLASS1 mlHistorical