FDA.reportPublic FDA data

Kineret

Product NDC
66658-234
11-digit product format
666580234
Labeler code
66658
Product ID
66658-234_d1acb9d5-9241-4aeb-b3e7-f05dbc8c15a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
anakinra
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Swedish Orphan Biovitrum AB (publ)
Application
BLA103950
Marketing category
BLA
Marketing start
2009-12-15
Substance
ANAKINRA
Active strength
100 mg/.67mL
Pharmacologic classes
Interleukin 1 Receptor Antagonists [MoA], Interleukin-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Kineret
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANAKINRA100 mg/.67mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9013DUQ28KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
727711Internal RxNorm lookup
727714Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9d74915-6606-4570-9c52-c4001d3177deAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
66658-234-07These highlights do not include all the information needed to use KINERET safely and effectively. See full prescribing information for KINERET. KINERET® (anakinra) injection, for subcutaneous use Initial U.S. Approval: 2001
66658-234-07These highlights do not include all the information needed to use KINERET safely and effectively. See full prescribing information for KINERET. KINERET® (anakinra) injection, for subcutaneous use Initial U.S. Approval: 2001
66658-234-07These highlights do not include all the information needed to use KINERET safely and effectively. See full prescribing information for KINERET. KINERET® (anakinra) injection, for subcutaneous use Initial U.S. Approval: 2001
66658-234-28These highlights do not include all the information needed to use KINERET safely and effectively. See full prescribing information for KINERET. KINERET® (anakinra) injection, for subcutaneous use Initial U.S. Approval: 2001
66658-234-28These highlights do not include all the information needed to use KINERET safely and effectively. See full prescribing information for KINERET. KINERET® (anakinra) injection, for subcutaneous use Initial U.S. Approval: 2001
66658-234-28These highlights do not include all the information needed to use KINERET safely and effectively. See full prescribing information for KINERET. KINERET® (anakinra) injection, for subcutaneous use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66658-234-07Kineret7 in 1 CARTONINJECTION, SOLUTION724
66658-234-07Kineret0.67 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.6724
66658-234-28Kineret7 in 1 CARTONINJECTION, SOLUTION724
66658-234-28Kineret4 in 1 CASEINJECTION, SOLUTION424

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66658-234-01ML - Milliliter66658-234a4759595-d3f5-4ff7-853a-b73f4961d25812013-07-02
66658-234-07ML - Milliliter66658-23447a840a1-6b11-43aa-8b5b-bc71f843da6712012-07-24
66658-234-28ML - Milliliter66658-234b905f1b6-4287-430d-8630-7788c43d246a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
anakinraACTIVE INGREDIENT9013DUQ28KKINERET (ANAKINRA) INJECTION, SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]13
anakinraACTIVE MOIETY9013DUQ28KKINERET (ANAKINRA) INJECTION, SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]13
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLKINERET (ANAKINRA) INJECTION, SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]13
edetate disodiumINACTIVE INGREDIENT7FLD91C86KKINERET (ANAKINRA) INJECTION, SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]13
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HKINERET (ANAKINRA) INJECTION, SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]13
sodium chlorideINACTIVE INGREDIENT451W47IQ8XKINERET (ANAKINRA) INJECTION, SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]13
WaterINACTIVE INGREDIENT059QF0KO0RKINERET (ANAKINRA) INJECTION, SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66658-234KINERET (ANAKINRA) INJECTION, SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]21Current NDC, Legacy NDC, 4 package rows20241115_d9d74915-6606-4570-9c52-c4001d3177de.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
KineretANAKINRASwedish Orphan Biovitrum AB (publ)d9d74915-6606-4570-9c52-c4001d3177de2026-04-03Warnings, Adverse reactionsExact identifier
application number: BLA103950
ndc (product): 66658-234

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103950Kineretanakinra351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727711anakinra 100 MG in 0.67 ML Prefilled SyringePSNd9d74915-6606-4570-9c52-c4001d3177de24
727714Kineret 100 MG in 0.67 ML Prefilled SyringePSNd9d74915-6606-4570-9c52-c4001d3177de24
7277140.67 ML anakinra 149 MG/ML Prefilled Syringe [Kineret]SBDd9d74915-6606-4570-9c52-c4001d3177de24
7277110.67 ML anakinra 149 MG/ML Prefilled SyringeSCDd9d74915-6606-4570-9c52-c4001d3177de24
727711anakinra 100 MG per 0.67 ML Prefilled SyringeSYd9d74915-6606-4570-9c52-c4001d3177de24
727714Kineret 100 MG per 0.67 ML Prefilled SyringeSYd9d74915-6606-4570-9c52-c4001d3177de24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66658-234-07666580234077 SYRINGE, GLASS in 1 CARTON (66658-234-07) / .67 mL in 1 SYRINGE, GLASS2009-12-150000-00-00NoNoCurrent
66658-234-28666580234284 CARTON in 1 CASE (66658-234-28) / 7 SYRINGE, GLASS in 1 CARTON / .67 mL in 1 SYRINGE, GLASS4 carton2009-12-150000-00-00NoNoCurrent