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 Identifiers#

Field, Values table
FieldValues
Unii9013DUQ28K
Rxcui727711, 727714

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66658-234-072025-07-30C16284748780-13b156c62-2c7c-fb37-e063-e6dba90a4e07These 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
66658-234-072025-07-30C16284748780-13b156c62-2c7c-fb37-e063-e6dba90a4e07These 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
66658-234-072025-07-30C16284748780-13b156c62-2c7c-fb37-e063-e6dba90a4e07These 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
66658-234-282025-07-30C16284748780-13b156c62-2c7c-fb37-e063-e6dba90a4e07These 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
66658-234-282025-07-30C16284748780-13b156c62-2c7c-fb37-e063-e6dba90a4e07These 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
66658-234-282025-07-30C16284748780-13b156c62-2c7c-fb37-e063-e6dba90a4e07These 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

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