Home NDC 71104-983 ALTUVIIIO
Product NDC 71104-983
11-digit product format 711040983
Labeler code 71104
Product ID 71104-983_53f2b610-41b6-4485-ad9c-e7f445628ee5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl
Dosage form KIT
Labeler Bioverativ Therapeutics Inc.
Application BLA125771
Marketing category BLA
Marketing start 2023-02-22
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base ALTUVIIIO
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2631088 Internal RxNorm lookup 2631093 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 71104-983-01 ALTUVIIIO 1 in 1 KIT KIT 1 10 71104-990-08 ALTUVIIIO 3 mL in 1 VIAL POWDER, FOR SOLUTION 3 mL 3000 [iU] in 3mL 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71104-983 ALTUVIIIO (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC-VWF-XTEN FUSION PROTEIN-EHTL) KIT [BIOVERATIV THERAPEUTICS INC.] 7 Current NDC, 2 package rows 20250313_01411972-df40-4ccf-88f0-d3220e5abda9.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ALTUVIIIO ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC-VWF-XTEN FUSION PROTEIN-EHTL Bioverativ Therapeutics Inc. 01411972-df40-4ccf-88f0-d3220e5abda9 2026-02-23 Warnings, Adverse reactions Exact identifier application number: BLA125771 ndc (product): 71104-983
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125771 ALTUVIIIO antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71104-983-01 71104098301 1 KIT in 1 KIT (71104-983-01) * 3 mL in 1 VIAL (71104-990-08) * 3 mL in 1 SYRINGE (71104-035-01) 1 kit 2023-02-22 No No Current 71104-990-08 71104099008 3 mL in 1 VIAL 3 ml Historical