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 Identifiers#

Field, Values table
FieldValues
Rxcui2110616, 2110618

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

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