Home NDC 0078-0883-61 ADAKVEO
Product NDC 0078-0883
Requested package NDC 0078-0883-61
11-digit product format 000780883
Labeler code 0078
Product ID 0078-0883_94577a82-7545-4421-ade9-108653361a16
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 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ADAKVEO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CRIZANLIZUMAB 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7451S9126 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2262425 Internal RxNorm lookup 2262430 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-0883-61 ADAKVEO 10 mL in 1 VIAL, GLASS INJECTION 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0883 ADAKVEO (CRIZANLIZUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION] 6 Current NDC, Legacy NDC, 1 package rows 20240702_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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761128 Adakveo crizanlizumab-tmca 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0883-61 00078088361 10 mL in 1 VIAL, GLASS (0078-0883-61) 10 ml 2019-11-15 0000-00-00 No No Current