Home NDC 0078-0734 Ilaris
Product NDC 0078-0734
11-digit product format 000780734
Labeler code 0078
Product ID 0078-0734_45376297-5629-4f69-a583-48a97e905a82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name canakinumab
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Novartis Pharmaceuticals Corporation
Application BLA125319
Marketing category BLA
Marketing start 2016-12-22
Substance CANAKINUMAB
Active strength 150 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Ilaris
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CANAKINUMAB 150 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 37CQ2C7X93 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1864324 Internal RxNorm lookup 1864326 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 0078-0734-61 Ilaris 1 in 1 CARTON INJECTION, SOLUTION 1 30 0078-0734-61 Ilaris 1 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 1 30
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CANAKINUMAB ACTIVE INGREDIENT 37CQ2C7X93 ILARIS (CANAKINUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 14 CANAKINUMAB ACTIVE MOIETY 37CQ2C7X93 ILARIS (CANAKINUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 14 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ILARIS (CANAKINUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 14 SUCROSE INACTIVE INGREDIENT C151H8M554 ILARIS (CANAKINUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 14 WATER INACTIVE INGREDIENT 059QF0KO0R ILARIS (CANAKINUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0734 ILARIS (CANAKINUMAB) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 29 Current NDC, Legacy NDC, 2 package rows 20241108_7d271f3b-e4f9-4d80-8dcf-28d49123f80e.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ilaris CANAKINUMAB Novartis Pharmaceuticals Corporation 7d271f3b-e4f9-4d80-8dcf-28d49123f80e 2026-06-08 Warnings, Adverse reactions Exact identifier application number: BLA125319 ndc (product): 0078-0734
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125319 Ilaris canakinumab 351(a) Disc 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0078-0734-61 00078073461 1 VIAL, SINGLE-USE in 1 CARTON (0078-0734-61) / 1 mL in 1 VIAL, SINGLE-USE 2016-12-22 0000-00-00 No No Current