Home NDC 71127-5000 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 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sevenfact COAGULATION FACTOR VIIA RECOMBINANT HUMAN Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.) b23ad666-8ce0-4e0b-9eff-c6983ac5f7e6 2025-11-19 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125641 ndc (product): 71127-5000
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 Identifier FDA.report destination 2386865 Internal RxNorm lookup 2386870 Internal RxNorm lookup 2386872 Internal RxNorm lookup 2386874 Internal RxNorm lookup 2696277 Internal RxNorm lookup 2696279 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71127-5000-1 Sevenfact 1 in 1 PACKAGE KIT 1 11 71127-5100-1 Sevenfact 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 mL 5 mg in 5mL 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71127-5000 SEVENFACT (COAGULATION FACTOR VIIA RECOMBINANT HUMAN) KIT [LABORATOIRE FRANÇAIS DU FRACTIONNEMENT ET DES BIOTECHNOLOGIES SOCIÉTÉ ANONYME (LFB S.A.)] 9 Current NDC, Legacy NDC, 2 package rows 20250325_b23ad666-8ce0-4e0b-9eff-c6983ac5f7e6.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125641 Sevenfact coagulation factor VIIa (recombinant)-jncw 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71127-5000-1 71127500001 1 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 kit 2020-12-10 0000-00-00 No No Current 71127-5100-1 71127510001 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical