FDA.reportPublic FDA data

Ixinity

Product NDC
70504-0288
11-digit product format
705040288
Labeler code
70504
Product ID
70504-0288_6f483b65-2f54-4dab-ab99-946eb6b6b418
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
coagulation factor IX (recombinant)
Dosage form
KIT
Labeler
Aptevo BioTherapeutics LLC
Application
BLA125426
Marketing category
BLA
Marketing start
2017-05-12
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70504-0288IInactivated by FDA2026-07-31
excluded packagepackage70504-028870504-0288-5IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IxinityCOAGULATION FACTOR IX (RECOMBINANT)Medexus Pharma, Inc.26bc221d-c9bc-4aba-92f3-6c21acaaf1942024-04-03Warnings, Adverse reactionsExact identifier
application number: BLA125426

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70504-0288-52023-01-30C16284748780-1f386c649-9b72-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use IXINITY® safely and effectively. See full prescribing information for IXINITY.. IXINITY [coagulation factor IX (recombinant)] Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70504-0276-1Ixinity5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,5 mL2000 [iU] in 5mL10
70504-0288-5Ixinity1 in 1 CARTONKIT110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70504-0288-5EA - Each70504-0288e1b9614c-1092-4ab6-86b8-eae78159478212017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70504-0288IXINITY (COAGULATION FACTOR IX (RECOMBINANT)) KIT [APTEVO BIOTHERAPEUTICS LLC]10Legacy NDC, 2 package rows20210305_9521898c-61aa-44ab-8ab8-84274ca19943.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125426IxinityCoagulation Factor IX (Recombinant)351(a)Disc2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666311coagulation factor IX (recombinant human) 1 UNT InjectionPSN9521898c-61aa-44ab-8ab8-84274ca1994310
1666328IXINITY 1 UNT InjectionPSN9521898c-61aa-44ab-8ab8-84274ca1994310
1666328nonacog alfa 1 UNT Injection [Ixinity]SBD9521898c-61aa-44ab-8ab8-84274ca1994310
1666311nonacog alfa 1 UNT InjectionSCD9521898c-61aa-44ab-8ab8-84274ca1994310
1666328Ixinity (coagulation factor IX (recombinant human)) 1 UNT InjectionSY9521898c-61aa-44ab-8ab8-84274ca1994310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70504-0276-1705040276015 mL in 1 VIAL5 mlHistorical
70504-0288-5705040288051 KIT in 1 CARTON (70504-0288-5) * 5 mL in 1 VIAL (70504-0276-1) * 5 mL in 1 SYRINGE (70504-0280-1) 1 kit2017-05-120000-00-00NoNoCurrent