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 14 of 65 · 1,292 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tap Water Detox 6018TAP WATER DETOXProfessional Complementary Health Formulasae0bca6a-118e-40a2-9108-14fc415524442026-01-08WarningsExact identifier
unii: 789U1901C5
Opsin II 6015OPSIN IIProfessional Complementary Health Formulas848d620e-ddd5-4787-a4bd-844be76154322026-01-08WarningsExact identifier
unii: 451W47IQ8X
L-Histidine High 7410L-HISTIDINE HIGHProfessional Complementary Health Formulas7eec7d23-236f-4770-9587-1bf602fd91c22026-01-08WarningsExact identifier
unii: 4QD397987E
Northwest Regional 1019NORTHWEST REGIONALProfessional Complementary Health Formulas4dccc9f6-4d9e-4eec-b031-1fccdddb3d032026-01-08WarningsExact identifier
unii: 451W47IQ8X
Headache Drops 2027HEADACHE DROPSProfessional Complementary Health Formulasa7e345fb-c4aa-4b10-8074-9d8c373041422026-01-08WarningsExact identifier
unii: 451W47IQ8X
Asthma Drops 2010ASTHMA DROPSProfessional Complementary Health Formulasb9f234ad-a5ff-40a9-bc51-c192f30140902026-01-08WarningsExact identifier
unii: 789U1901C5
Bone Stim Liquescence 3005BONE STIM LIQUESCENCEProfessional Complementary Health Formulas6e62dde0-adf2-4cdd-8340-abc6b10db3572026-01-08WarningsExact identifier
unii: M4I0D6VV5M
Metab 6012METABProfessional Complementary Health Formulasf3576d6f-c9ab-4370-8a32-b6c4bf6ba4fd2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: 451W47IQ8X
Shingles Nosode 4028SHINGLES NOSODEProfessional Complementary Health Formulase71d917a-af9f-41e9-a3de-cb588db7e0222026-01-08WarningsExact identifier
unii: 451W47IQ8X
Substance Abuse Drops 2063SUBSTANCE ABUSE DROPSProfessional Complementary Health Formulas61f8263d-6f72-442f-a09e-57daf7226cc72026-01-08WarningsExact identifier
unii: C151H8M554
Immune System Stimulator Drops 2033IMMUNE SYSTEM STIMULATOR DROPSProfessional Complementary Health Formulasf4595c63-1c9c-48a6-a13a-3659991f455b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Gallbladder 7007RET GALLBLADDERProfessional Complementary Health Formulas82bc7b50-aea3-4993-b171-919940fef2972026-01-08WarningsExact identifier
unii: 789U1901C5
unii: 451W47IQ8X
Anti-Smoking I Drops 2007ANTI-SMOKING I DROPSProfessional Complementary Health Formulas1c6b5b98-971d-442a-b9eb-37f65409a5212026-01-08WarningsExact identifier
unii: C151H8M554
Libido Stim Liquescence 3014LIBIDO STIM LIQUESCENCEProfessional Complementary Health Formulas3d59b77d-817b-4021-a6dd-75d3b4b608662026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Pituitary/Sex 7012RET PITUITARY/SEXProfessional Complementary Health Formulas5081185c-1598-4bf5-b47b-b15135c453fb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Pineal Liquescence 3030PINEAL LIQUESCENCEProfessional Complementary Health Formulas3574f919-0b93-4bf5-9ee9-8fadda5668c32026-01-08WarningsExact identifier
unii: SY7Q814VUP
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: C151H8M554
Melancholy Drops Extrovert 2015MELANCHOLY DROPS EXTROVERTProfessional Complementary Health Formulas2c9187ce-a52e-445e-a36e-fe374f5ad2e22026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Lung 7003RET LUNGProfessional Complementary Health Formulas2ed03832-f226-4b3c-9ee6-5352f8d79fdb2026-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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