FDA.reportPublic FDA data

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
IngredientStrength
RILONACEPT160 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8K80YB5GMGInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
763453Internal RxNorm lookup
763457Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ad965f38-dd22-4607-a673-2fb92f3b527aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
82859377-bb37-4b99-bc88-4c78558a1c99Product name120210916
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73604-914-01Arcalyst2 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,216
73604-914-01Arcalyst1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,116
73604-914-04Arcalyst2 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,216
73604-914-04Arcalyst4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73604-914-01EA - Each73604-91440f38c50-2464-4d35-a65c-d905434545cf12021-07-15
73604-914-04EA - Each73604-914c3b88234-6387-4d7f-b912-bcf15c9feacf12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73604-914ARCALYST (RILONACEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [KINIKSA PHARMACEUTICALS (UK), LTD.]13Current NDC, Legacy NDC, 4 package rows20250313_ad965f38-dd22-4607-a673-2fb92f3b527a.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ArcalystRILONACEPTKiniksa Pharmaceuticals (UK), Ltd.ad965f38-dd22-4607-a673-2fb92f3b527a2025-12-16Warnings, Adverse reactionsExact identifier
application number: BLA125249
ndc (product): 73604-914

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125249Arcalystrilonacept351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763457Arcalyst 220 MG InjectionPSNad965f38-dd22-4607-a673-2fb92f3b527a16
763453rilonacept 220 MG InjectionPSNad965f38-dd22-4607-a673-2fb92f3b527a16
763457rilonacept 220 MG Injection [Arcalyst]SBDad965f38-dd22-4607-a673-2fb92f3b527a16
763453rilonacept 220 MG InjectionSCDad965f38-dd22-4607-a673-2fb92f3b527a16
763457Arcalyst 220 MG InjectionSYad965f38-dd22-4607-a673-2fb92f3b527a16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73604-914-01736040914011 VIAL, SINGLE-USE in 1 CARTON (73604-914-01) / 2 mL in 1 VIAL, SINGLE-USE2021-06-180000-00-00NoNoCurrent
73604-914-04736040914044 VIAL, SINGLE-USE in 1 CARTON (73604-914-04) / 2 mL in 1 VIAL, SINGLE-USE2008-03-240000-00-00NoNoCurrent