FDA.reportPublic FDA data

ADAKVEO

Product NDC
0078-0883
11-digit product format
000780883
Labeler code
0078
Product ID
0078-0883_659b0142-cf3f-4af9-ad14-79f8c88978af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
crizanlizumab
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Novartis Pharmaceuticals Corporation
Application
BLA761128
Marketing category
BLA
Marketing start
2019-11-15
Substance
CRIZANLIZUMAB
Active strength
10 mg/mL
Pharmacologic classes
P-Selectin Blockers [MoA], Selectin Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CRIZANLIZUMAB10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7451S9126Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2262425Internal RxNorm lookup
2262430Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b2b7f8b4-fe9a-4a86-8129-9e43f99a20c6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bbdd8039-df53-4f41-b65e-864d183a25caProduct name120200429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0883-61ADAKVEO10 mL in 1 VIAL, GLASSINJECTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0883-61ML - Milliliter0078-08833974e79f-7fba-41ff-b728-ff0c6f612f8812019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0883ADAKVEO (CRIZANLIZUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]6Current NDC, Legacy NDC, 1 package rows20240702_b2b7f8b4-fe9a-4a86-8129-9e43f99a20c6.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
ADAKVEOCRIZANLIZUMABNovartis Pharmaceuticals Corporationb2b7f8b4-fe9a-4a86-8129-9e43f99a20c62026-06-04Warnings, Adverse reactionsExact identifier
application number: BLA761128
ndc (product): 0078-0883

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761128Adakveocrizanlizumab-tmca351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2262430ADAKVEO 100 MG in 10 ML InjectionPSNb2b7f8b4-fe9a-4a86-8129-9e43f99a20c67
2262425crizanlizumab-tmca 100 MG in 10 ML InjectionPSNb2b7f8b4-fe9a-4a86-8129-9e43f99a20c67
226243010 ML crizanlizumab-tmca 10 MG/ML Injection [Adakveo]SBDb2b7f8b4-fe9a-4a86-8129-9e43f99a20c67
226242510 ML crizanlizumab-tmca 10 MG/ML InjectionSCDb2b7f8b4-fe9a-4a86-8129-9e43f99a20c67
2262430Adakveo 10 MG/ML per 10 ML InjectionSYb2b7f8b4-fe9a-4a86-8129-9e43f99a20c67
2262430Adakveo 100 MG per 10 ML InjectionSYb2b7f8b4-fe9a-4a86-8129-9e43f99a20c67
2262425crizanlizumab-tmca 100 MG per 10 ML InjectionSYb2b7f8b4-fe9a-4a86-8129-9e43f99a20c67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0883-610007808836110 mL in 1 VIAL, GLASS (0078-0883-61) 10 ml2019-11-150000-00-00NoNoCurrent