NDC 61755-001

Arcalyst

Rilonacept

Arcalyst is a Subcutaneous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Regeneron Pharmaceuticals, Inc.. The primary component is Rilonacept.

• Product ID: 61755-001_22064073-20bd-4467-8910-9d1f9e2eaacc
• NDC: 61755-001
• Product Type: Human Prescription Drug
• Proprietary Name: Arcalyst
• Generic Name: Rilonacept
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2008-02-27
• Marketing End Date: 2022-01-31
• Marketing Category: BLA / BLA
• Application Number: BLA125249
• Labeler Name: Regeneron Pharmaceuticals, Inc.
• Substance Name: RILONACEPT
• Active Ingredient Strength: 160 mg/2mL
• NDC Exclude Flag: N

Packaging

NDC 61755-001-01

4 VIAL, SINGLE-USE in 1 CARTON (61755-001-01) > 2 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2008-03-24
• Marketing End Date: 2022-01-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61755-001-01 [61755000101]

Arcalyst INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125249
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-03-24

Drug Details

Active Ingredients

Ingredient	Strength
RILONACEPT	160 mg/2mL

OpenFDA Data

• SPL SET ID: 282f4099-e848-432a-bac1-e041c192a5ba
• Manufacturer:
  • Regeneron Pharmaceuticals, Inc.
• UNII:
  • 8K80YB5GMG
• RxNorm Concept Unique ID - RxCUI:
  • 763457
  • 763453

NDC Crossover Matching brand name "Arcalyst" or generic name "Rilonacept"

NDC	Brand Name	Generic Name
61755-001	Arcalyst	rilonacept
73604-914	Arcalyst	rilonacept