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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 37CQ2C7X93 |
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 |
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 |