FDA.reportPublic FDA data

NDC 0026-0426 - Kovaltry

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0026-0426
Package NDCs from labels
0026-0426-02, 0026-0426-05, 0026-0426-15
Manufacturer
Bayer HealthCare LLC
Effective date
2026-03-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Kovaltry - Bayer HealthCare LLCBayer HealthCare LLC2026-03-02PLASMA DERIVATIVE
Jivi - Bayer HealthCare LLCBayer HealthCare LLC2026-03-02PLASMA DERIVATIVE
Kogenate FSBayer HealthCare LLC | Bayer Healthcare Manufacturing Srl | BioReliance Corporation | Nelson Laboratories, LLC | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) | Bayer AG | Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Helmut-Vetter-Strasse)2019-12-20PLASMA DERIVATIVE

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0026-0426KOVALTRY (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC]16Unmatched20241010_89ba5048-469c-4f08-a173-81b0c6f3004d.zip
0026-0426KOGENATE FS (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC]15Unmatched20241210_01c6292d-b670-415b-9d8e-7df92c0adc0f.zip
0026-0426JIVI (ANTIHEMOPHILIC FACTOR (RECOMBINANT) PEGYLATED-AUCL) KIT [BAYER HEALTHCARE LLC]11Unmatched20250529_f04e5bd5-d7e2-453b-a407-2616d81a695d.zip

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

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 13 of 65 · 1,292 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Weight Management Formula 7534WEIGHT MANAGEMENT FORMULAProfessional Complementary Health Formulasf0406b63-7b97-4b2c-b976-75e8890818c62026-01-08WarningsExact identifier
unii: 451W47IQ8X
Vermex 6016VERMEXProfessional Complementary Health Formulasa8a70546-ae5d-4524-b6bc-3dc0a989faec2026-01-08WarningsExact identifier
unii: 789U1901C5
Acne Drops 2001ACNE DROPSProfessional Complementary Health Formulas340fc7dc-2aa4-411f-842b-4ce7046717222026-01-08WarningsExact identifier
unii: 451W47IQ8X
Radialgin 6002RADIALGINProfessional Complementary Health Formulas5e7ce7a0-9f43-4a69-89e9-a59692a8de412026-01-08WarningsExact identifier
unii: 451W47IQ8X
Difficulty Breathing Drops 2171DIFFICULTY BREATHING DROPSProfessional Complementary Health Formulas30bab475-47dd-4261-b497-1f8edf9dd4112026-01-08WarningsExact identifier
unii: 789U1901C5
Viral Immune Stimulator 6017VIRAL IMMUNE STIMULATORProfessional Complementary Health Formulasf462cfb7-e1c3-4ded-9f79-f1983517fe152026-01-08WarningsExact identifier
unii: 451W47IQ8X
Pituitary Liquescence 3018PITUITARY LIQUESCENCEProfessional Complementary Health Formulasa32e9ea9-5ff9-4951-9244-7b3253456b5f2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Psorinum Combination 9237PSORINUM COMBINATIONProfessional Complementary Health Formulas8b2a133d-9681-4091-a6d1-4ecc4583626b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Adrenal Liquescence 3001ADRENAL LIQUESCENCEProfessional Complementary Health Formulas0388d3c7-4b3b-4e74-8c1b-9a2af2a4377d2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Anti-Constipation Drops 2077ANTI-CONSTIPATION DROPSProfessional Complementary Health Formulas55d105fe-5698-43a6-9252-eaa9b63299d02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Anxious Drops 2098ANXIOUS DROPSProfessional Complementary Health Formulasa5dc8619-074a-4c1f-8bb2-fea788f5aff12026-01-08WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus Liquescence 3023SPLEEN THYMUS LIQUESCENCEProfessional Complementary Health Formulasabe3c5c4-c5b4-47dd-afe3-b7858c82f7752026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Bladder 7006RET BLADDERProfessional Complementary Health Formulasf1d354e7-3d72-40aa-aaf1-172cb39f07112026-01-08WarningsExact identifier
unii: 451W47IQ8X
Epilepsy Drops 2020EPILEPSY DROPSProfessional Complementary Health Formulasb5cc19d2-5200-498c-9742-5967d90479282026-01-08WarningsExact identifier
unii: 789U1901C5
Cuprum metallicum 7116CUPRUM METALLICUMProfessional Complementary Health Formulas1bc52b85-d64d-4a3f-bce7-9e3762d28af92026-01-08WarningsExact identifier
unii: 789U1901C5
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: 451W47IQ8X
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: C151H8M554
Psorinum Miasm Drops 2054PSORINUM MIASM DROPSProfessional Complementary Health Formulasa34aadab-b634-461f-a0ff-58f42f6e08332026-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.