FDA.reportPublic FDA data

Kogenate FS

Product NDC
0026-3782
Requested package NDC
0026-3782-25
11-digit product format
000263782
Labeler code
0026
Product ID
0026-3782_95810928-b700-4a13-8d83-f19f1539e822
Type
PLASMA DERIVATIVE
Nonproprietary name
Antihemophilic Factor (Recombinant)
Dosage form
KIT
Labeler
Bayer HealthCare LLC
Application
BLA103332
Marketing category
BLA
Marketing start
2013-06-26
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0026-37820026-3782-25DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0026-3782-20EA - Each0026-37824083a455-7e5c-409a-a0e1-e85a2724245512012-07-24
0026-3782-25EA - Each0026-3782ad97e909-7122-41c5-8ec1-74c76a77654e12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTACTIVE INGREDIENTP89DR4NY54KOGENATE FS (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC]7
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTACTIVE MOIETYP89DR4NY54KOGENATE FS (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC]7
CALCIUMINACTIVE INGREDIENTSY7Q814VUPKOGENATE FS (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC]7
CHLORIDE IONINACTIVE INGREDIENTQ32ZN48698KOGENATE FS (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC]7
COPPERINACTIVE INGREDIENT789U1901C5KOGENATE FS (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC]7
GLYCINEINACTIVE INGREDIENTTE7660XO1CKOGENATE FS (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC]7
HISTIDINEINACTIVE INGREDIENT4QD397987EKOGENATE FS (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HKOGENATE FS (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC]7
SODIUM POLYMETAPHOSPHATEINACTIVE INGREDIENTP1BM4ZH95LKOGENATE FS (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC]7
SUCROSEINACTIVE INGREDIENTC151H8M554KOGENATE FS (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC]7
TRI-N-BUTYL PHOSPHATEINACTIVE INGREDIENT95UAS8YAF5KOGENATE FS (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0026-3782KOGENATE FS (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC]15Legacy NDC20241210_01c6292d-b670-415b-9d8e-7df92c0adc0f.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103332Helixate Fs, Kogenate, Kogenate FsAntihemophilic Factor (Recombinant)351(a)Disc2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0026-3782-25000263782251 KIT in 1 BOX (0026-3782-25) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4782-01) * 2.5 mL in 1 SYRINGE (0026-0426-02) 1 kit2013-06-260000-00-00NoNoCurrent