Home NDC 71127-5000 Sevenfact
Product NDC 71127-5000
11-digit product format 711275000
Labeler code 71127
Product ID 71127-5000_7a6bb0f4-e2de-4329-9cd8-b267f2c28b9e
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sevenfact
Listing expiration 2027-12-31 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 2026-09-01
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