FDA.reportPublic FDA data

Sevenfact

Product NDC
71127-5000
11-digit product format
711275000
Labeler code
71127
Product ID
71127-5000_b468e3d0-7f2d-47fc-ae87-888cf8c3d7f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Coagulation Factor VIIa Recombinant Human
Dosage form
KIT
Route
INTRAVENOUS
Labeler
Laboratoire Fran�ais du Fractionnement et des Biotechnologies Soci�t� Anonyme (LFB S.A.)
Application
BLA125641
Marketing category
BLA
Marketing start
2020-12-10
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui2386865, 2386870, 2386872, 2386874, 2696277, 2696279

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71127-5000-1Sevenfact1 in 1 PACKAGEKIT111
71127-5100-1Sevenfact5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,5 mL5 mg in 5mL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71127-5000SEVENFACT (COAGULATION FACTOR VIIA RECOMBINANT HUMAN) KIT [LABORATOIRE FRANÇAIS DU FRACTIONNEMENT ET DES BIOTECHNOLOGIES SOCIÉTÉ ANONYME (LFB S.A.)]9Current NDC, Legacy NDC, 2 package rows20250325_b23ad666-8ce0-4e0b-9eff-c6983ac5f7e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2386872coagulation factor VIIa (recombinant)-jncw 1 MG InjectionPSNb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2696277coagulation factor VIIa (recombinant)-jncw 2 MG InjectionPSNb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2386865coagulation factor VIIa (recombinant)-jncw 5 MG InjectionPSNb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2386874SevenFACT 1 MG InjectionPSNb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2696279SevenFACT 2 MG InjectionPSNb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2386870SevenFACT 5 MG InjectionPSNb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2386874coagulation factor VIIa (recombinant)-jncw 1 MG Injection [Sevenfact]SBDb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2696279coagulation factor VIIa (recombinant)-jncw 2 MG Injection [Sevenfact]SBDb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2386870coagulation factor VIIa (recombinant)-jncw 5 MG Injection [Sevenfact]SBDb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2386872coagulation factor VIIa (recombinant)-jncw 1 MG InjectionSCDb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2696277coagulation factor VIIa (recombinant)-jncw 2 MG InjectionSCDb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2386865coagulation factor VIIa (recombinant)-jncw 5 MG InjectionSCDb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2386872factor VIIa recombinant-jncw 1 MG InjectionSYb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2386865factor VIIa recombinant-jncw 5 MG InjectionSYb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2386874Sevenfact 1 MG InjectionSYb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2696279Sevenfact 2 MG InjectionSYb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611
2386870Sevenfact 5 MG InjectionSYb23ad666-8ce0-4e0b-9eff-c6983ac5f7e611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71127-5000-1711275000011 KIT in 1 PACKAGE (71127-5000-1) * 5 mL in 1 VIAL, SINGLE-DOSE (71127-5100-1) * 5.2 mL in 1 SYRINGE (71127-5200-1) 1 kit2020-12-100000-00-00NoNoCurrent
71127-5100-1711275100015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical