Arcalyst
- Product NDC
- 73604-914
- 11-digit product format
- 736040914
- Labeler code
- 73604
- Product ID
- 73604-914_11e22c54-9b9a-4f9f-8680-cb7327511a23
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rilonacept
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Kiniksa Pharmaceuticals (UK), Ltd.
- Application
- BLA125249
- Marketing category
- BLA
- Marketing start
- 2008-02-27
- Substance
- RILONACEPT
- Active strength
- 160 mg/2mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Arcalyst
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RILONACEPT | 160 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8K80YB5GMG |
| Rxcui | 763453, 763457 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73604-914-01 | Arcalyst | 2 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 2 | | 16 |
| 73604-914-01 | Arcalyst | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 16 |
| 73604-914-04 | Arcalyst | 2 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 2 | | 16 |
| 73604-914-04 | Arcalyst | 4 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 4 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73604-914 | ARCALYST (RILONACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [KINIKSA PHARMACEUTICALS (UK), LTD.] | 13 | Current NDC, Legacy NDC, 4 package rows | 20250313_ad965f38-dd22-4607-a673-2fb92f3b527a.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 |
|---|
| 73604-914-01 | 73604091401 | 1 VIAL, SINGLE-USE in 1 CARTON (73604-914-01) / 2 mL in 1 VIAL, SINGLE-USE | 2021-06-18 | 0000-00-00 | No | No | Current |
| 73604-914-04 | 73604091404 | 4 VIAL, SINGLE-USE in 1 CARTON (73604-914-04) / 2 mL in 1 VIAL, SINGLE-USE | 2008-03-24 | 0000-00-00 | No | No | Current |