Ilaris (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

NDC 0078-0734-61

Rx only

ILARIS®
(canakinumab)Injection

150 mg/mL

For Subcutaneous Use

Single-Dose Vial. Discard Unused portion

Attention: Dispense with enclosed Medication Guide.

NOVARTIS

PRINCIPAL DISPLAY PANEL 
							NDC 0078-0734-61 
							ILARIS® 
							(canakinumab) 
							Injection 
							150 mg/mL
							For Subcutaneous Use
						    Single-Dose Vial. Discard Unused portion
							Attention: Dispense with enclosed Medication Guide.
							NOVARTIS
(click image for full-size original)

ILARIS canakinumab injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0734
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANAKINUMAB (CANAKINUMAB) CANAKINUMAB 150 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE 2.1 mg in 1 mL
HISTIDINE MONOHYDROCHLORIDE 1.3 mg in 1 mL
MANNITOL 49.2 mg in 1 mL
POLYSORBATE 80 0.4 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0734-61 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 1 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0078-0734-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125319 12/22/2016
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 08/2023 Novartis Pharmaceuticals Corporation

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