Home NDC 61755-001-01 Arcalyst
Product NDC 61755-001
Requested package NDC 61755-001-01
11-digit product format 617550001
Labeler code 61755
Product ID 61755-001_22064073-20bd-4467-8910-9d1f9e2eaacc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rilonacept
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route SUBCUTANEOUS
Labeler Regeneron Pharmaceuticals, Inc.
Application BLA125249
Marketing category BLA
Marketing start 2008-02-27
Marketing end 2022-01-31
Substance RILONACEPT
Active strength 160 mg/2mL
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded rilonacept ACTIVE INGREDIENT 8K80YB5GMG ARCALYST (RILONACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REGENERON PHARMACEUTICALS, INC.] 9 rilonacept ACTIVE MOIETY 8K80YB5GMG ARCALYST (RILONACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REGENERON PHARMACEUTICALS, INC.] 9 Arginine INACTIVE INGREDIENT 94ZLA3W45F ARCALYST (RILONACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REGENERON PHARMACEUTICALS, INC.] 9 Glycine INACTIVE INGREDIENT TE7660XO1C ARCALYST (RILONACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REGENERON PHARMACEUTICALS, INC.] 9 Histidine INACTIVE INGREDIENT 4QD397987E ARCALYST (RILONACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REGENERON PHARMACEUTICALS, INC.] 9 Polyethylene glycol 3350 INACTIVE INGREDIENT G2M7P15E5P ARCALYST (RILONACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REGENERON PHARMACEUTICALS, INC.] 9 Sucrose INACTIVE INGREDIENT C151H8M554 ARCALYST (RILONACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REGENERON PHARMACEUTICALS, INC.] 9
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Arcalyst RILONACEPT Kiniksa Pharmaceuticals (UK), Ltd. ad965f38-dd22-4607-a673-2fb92f3b527a 2025-12-16 Warnings, Adverse reactions Exact identifier application number: BLA125249
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125249 Arcalyst rilonacept 351(a) Rx 2026-06-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 61755-001-01 61755000101 4 VIAL, SINGLE-USE in 1 CARTON (61755-001-01) > 2 mL in 1 VIAL, SINGLE-USE 2008-03-24 2022-01-31 No No Current