FDA.reportPublic FDA data

Ixinity

Product NDC
59137-282
11-digit product format
591370282
Labeler code
59137
Product ID
59137-282_5e2b1242-2977-463b-ac2c-f89dadfba407
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
coagulation factor IX (recombinant)
Dosage form
KIT
Labeler
Medexus Pharma, Inc.
Application
BLA125426
Marketing category
BLA
Marketing start
2017-05-12
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ixinity
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1666311Internal RxNorm lookup
1666328Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
26bc221d-c9bc-4aba-92f3-6c21acaaf194Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59137-270-01Ixinity5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,5 mL500 [iU] in 5mL8
59137-282-05Ixinity1 in 1 CARTONKIT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59137-282-05EA - Each59137-28257a7020e-e95a-4b3a-9063-271f8f5b212612022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59137-282IXINITY (COAGULATION FACTOR IX (RECOMBINANT)) KIT [MEDEXUS PHARMA, INC.]8Current NDC, Legacy NDC, 2 package rows20240405_26bc221d-c9bc-4aba-92f3-6c21acaaf194.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
IxinityCOAGULATION FACTOR IX (RECOMBINANT)Medexus Pharma, Inc.26bc221d-c9bc-4aba-92f3-6c21acaaf1942024-04-03Warnings, Adverse reactionsExact identifier
application number: BLA125426
ndc (product): 59137-282

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 InjectionPSN26bc221d-c9bc-4aba-92f3-6c21acaaf1948
1666328IXINITY 1 UNT InjectionPSN26bc221d-c9bc-4aba-92f3-6c21acaaf1948
1666328nonacog alfa 1 UNT Injection [Ixinity]SBD26bc221d-c9bc-4aba-92f3-6c21acaaf1948
1666311nonacog alfa 1 UNT InjectionSCD26bc221d-c9bc-4aba-92f3-6c21acaaf1948
1666328Ixinity (coagulation factor IX (recombinant human)) 1 UNT InjectionSY26bc221d-c9bc-4aba-92f3-6c21acaaf1948

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59137-270-01591370270015 mL in 1 VIAL5 mlHistorical
59137-282-05591370282051 KIT in 1 CARTON (59137-282-05) * 5 mL in 1 VIAL (59137-270-01) * 5 mL in 1 SYRINGE (59137-280-01) 1 kit2021-07-010000-00-00NoNoCurrent