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

FDA-Initiated Inactive NDC Indexing#

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

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