NDC 0078-0582

Ilaris

Canakinumab

Ilaris is a Subcutaneous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Canakinumab.

• Product ID: 0078-0582_110863fe-9a07-49e2-85ea-f0442fc0eb41
• NDC: 0078-0582
• Product Type: Human Prescription Drug
• Proprietary Name: Ilaris
• Generic Name: Canakinumab
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2009-06-18
• Marketing End Date: 2020-02-29
• Marketing Category: BLA / BLA
• Application Number: BLA125319
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: CANAKINUMAB
• Active Ingredient Strength: 150 mg/mL
• NDC Exclude Flag: N

Packaging

NDC 0078-0582-61

1 VIAL, SINGLE-USE in 1 CARTON (0078-0582-61) > 1 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2009-06-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0582-61 [00078058261]

Ilaris INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125319
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-06-18
• Marketing End Date: 2020-02-29

Drug Details

Active Ingredients

Ingredient	Strength
CANAKINUMAB	150 mg/mL

OpenFDA Data

• SPL SET ID: 7d271f3b-e4f9-4d80-8dcf-28d49123f80e
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 37CQ2C7X93
• RxNorm Concept Unique ID - RxCUI:
  • 853494
  • 1864326
  • 853498
  • 1864324

NDC Crossover Matching brand name "Ilaris" or generic name "Canakinumab"

NDC	Brand Name	Generic Name
0078-0582	Ilaris	canakinumab
0078-0734	Ilaris	canakinumab