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

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
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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125641Sevenfactcoagulation factor VIIa (recombinant)-jncw351(a)Rx2026-06-01

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