ilaris

Generic: canakinumab

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name ilaris
Generic Name canakinumab
Labeler novartis pharmaceuticals corporation
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

canakinumab 150 mg/mL

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0734
Product ID 0078-0734_45376297-5629-4f69-a583-48a97e905a82
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125319
Listing Expiration 2026-12-31
Marketing Start 2016-12-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780734
Hyphenated Format 0078-0734

Supplemental Identifiers

RxCUI
1864324 1864326
UNII
37CQ2C7X93

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ilaris (source: ndc)
Generic Name canakinumab (source: ndc)
Application Number BLA125319 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 150 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0078-0734-61) / 1 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

0078-0734-61 1 VIAL, SINGLE-USE in 1 CARTON (0078-0734-61) / 1 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

canakinumab (150 mg/mL)

Linked Drug Pages (1)

Ilaris ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "45376297-5629-4f69-a583-48a97e905a82", "openfda": {"unii": ["37CQ2C7X93"], "rxcui": ["1864324", "1864326"], "spl_set_id": ["7d271f3b-e4f9-4d80-8dcf-28d49123f80e"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0078-0734-61)  / 1 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0078-0734-61", "marketing_start_date": "20161222"}], "brand_name": "Ilaris", "product_id": "0078-0734_45376297-5629-4f69-a583-48a97e905a82", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0078-0734", "generic_name": "canakinumab", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ilaris", "active_ingredients": [{"name": "CANAKINUMAB", "strength": "150 mg/mL"}], "application_number": "BLA125319", "marketing_category": "BLA", "marketing_start_date": "20161222", "listing_expiration_date": "20261231"}