Sevenfact

Product NDC
71127-1000
11-digit product format
711271000
Labeler code
71127
Product ID
71127-1000_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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2386865Internal RxNorm lookup
2386870Internal RxNorm lookup
2386872Internal RxNorm lookup
2386874Internal RxNorm lookup
2696277Internal RxNorm lookup
2696279Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b23ad666-8ce0-4e0b-9eff-c6983ac5f7e6Available on FDA.report

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
71127-1000-1Sevenfact1 in 1 PACKAGEKIT111
71127-1100-1Sevenfact1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1 mL1 mg in 1mL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71127-1000SEVENFACT (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

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
SevenfactCOAGULATION FACTOR VIIA RECOMBINANT HUMANLaboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.)b23ad666-8ce0-4e0b-9eff-c6983ac5f7e62025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125641
ndc (product): 71127-1000

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125641Sevenfactcoagulation factor VIIa (recombinant)-jncw351(a)Rx2026-08-01

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
71127-1000-1711271000011 KIT in 1 PACKAGE (71127-1000-1) * 1 mL in 1 VIAL, SINGLE-DOSE (71127-1100-1) * 1.1 mL in 1 SYRINGE (71127-1200-1) 1 kit2020-12-100000-00-00NoNoCurrent
71127-1100-1711271100011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical