FDA.reportPublic FDA data

Kovaltry

Product NDC
0026-3828
11-digit product format
000263828
Labeler code
0026
Product ID
0026-3828_f4bed724-db3e-448e-8947-2f6a6913f1ee
Type
PLASMA DERIVATIVE
Nonproprietary name
Antihemophilic Factor (Recombinant)
Dosage form
KIT
Labeler
Bayer HealthCare LLC
Application
BLA125574
Marketing category
BLA
Marketing start
2016-03-17
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Kovaltry
Listing expiration
2027-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
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
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0026-3828-50Kovaltry1 in 1 BOXKIT118
0026-3828-99Kovaltry1 in 1 BOXKIT118
0026-4828-01Kovaltry5 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,5 mL3000 [iU] in 5mL18
0026-4828-99Kovaltry5 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,5 mL3000 [iU] in 5mL18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0026-3828-50EA - Each0026-3828dd47fa89-e240-4ba8-aab3-9805aa8fa65f12016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0026-3828KOVALTRY (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC]16Current NDC, Legacy NDC, 4 package rows20241010_89ba5048-469c-4f08-a173-81b0c6f3004d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719222antihemophilic factor, human recombinant 1 UNT InjectionPSN89ba5048-469c-4f08-a173-81b0c6f3004d18
1743374Kovaltry 1 UNT InjectionPSN89ba5048-469c-4f08-a173-81b0c6f3004d18
1743374antihemophilic factor, human recombinant 1 UNT Injection [Kovaltry]SBD89ba5048-469c-4f08-a173-81b0c6f3004d18
1719222antihemophilic factor, human recombinant 1 UNT InjectionSCD89ba5048-469c-4f08-a173-81b0c6f3004d18
1719222factor VIII, human recombinant 1 UNT InjectionSY89ba5048-469c-4f08-a173-81b0c6f3004d18
1743374Kovaltry 1 UNT InjectionSY89ba5048-469c-4f08-a173-81b0c6f3004d18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0026-3828-50000263828501 KIT in 1 BOX (0026-3828-50) * 5 mL in 1 VIAL, SINGLE-USE (0026-4828-99) * 5 mL in 1 SYRINGE (0026-0426-15) * 5 mL in 1 VIAL, SINGLE-USE (0026-4828-01) * 5 mL in 1 SYRINGE (0026-0426-05) 1 kit2016-03-170000-00-00NoNoCurrent
0026-3828-99000263828991 KIT in 1 BOX (0026-3828-99) * 5 mL in 1 VIAL, SINGLE-USE (0026-4828-99) * 5 mL in 1 SYRINGE (0026-0426-15) * 5 mL in 1 VIAL, SINGLE-USE (0026-4828-01) * 5 mL in 1 SYRINGE (0026-0426-05) 1 kit2016-03-170000-00-00NoNoCurrent
0026-4828-01000264828015 mL in 1 VIAL, SINGLE-USE5 mlHistorical
0026-4828-99000264828995 mL in 1 VIAL, SINGLE-USE5 mlHistorical