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 Identifiers#

Field, Values table
FieldValues
Rxcui2631088, 2631093

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71104-983-01ALTUVIIIO1 in 1 KITKIT110
71104-990-08ALTUVIIIO3 mL in 1 VIALPOWDER, FOR SOLUTION3 mL3000 [iU] in 3mL10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71104-983ALTUVIIIO (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC-VWF-XTEN FUSION PROTEIN-EHTL) KIT [BIOVERATIV THERAPEUTICS INC.]7Current NDC, 2 package rows20250313_01411972-df40-4ccf-88f0-d3220e5abda9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2631093ALTUVIIIO 1 UNT InjectionPSN01411972-df40-4ccf-88f0-d3220e5abda910
2631088antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl 1 UNT InjectionPSN01411972-df40-4ccf-88f0-d3220e5abda910
2631093antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl 1 UNT Injection [Altuviiio]SBD01411972-df40-4ccf-88f0-d3220e5abda910
2631088antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl 1 UNT InjectionSCD01411972-df40-4ccf-88f0-d3220e5abda910
2631093Altuviiio 1 UNT InjectionSY01411972-df40-4ccf-88f0-d3220e5abda910
2631088antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl 1 UNT InjectionSY01411972-df40-4ccf-88f0-d3220e5abda910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71104-983-01711040983011 KIT in 1 KIT (71104-983-01) * 3 mL in 1 VIAL (71104-990-08) * 3 mL in 1 SYRINGE (71104-035-01) 1 kit2023-02-22NoNoCurrent
71104-990-08711040990083 mL in 1 VIAL3 mlHistorical