FDA.reportPublic FDA data

NDC 76125-252 - Koate

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
76125-252
Package NDCs from labels
76125-252-21
Manufacturer
KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA
Effective date
2023-12-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Koate - KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SAKEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA2023-12-13PLASMA DERIVATIVE
Koate - KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SAKEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA2023-12-12PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76125-252-21Koate5 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,5 mL250 [iU] in 5mL23
76125-252-21Koate5 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,5 mL250 [iU] in 5mL23
76125-252-21Koate5 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,5 mL250 [iU] in 5mL23
76125-252-21Koate5 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,5 mL250 [iU] in 5mL10
76125-252-21Koate5 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,5 mL250 [iU] in 5mL10
76125-252-21Koate5 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,5 mL250 [iU] in 5mL10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76125-252KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.]23Unmatched20231228_2f77d685-e382-b2e7-2414-0d3a3448688a.zip
76125-252KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.]10Unmatched20231228_865df1e2-b4d1-dbf5-2899-a9c02df4d122.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Antihemophilic Factor HumanACTIVE INGREDIENT839MOZ74GKKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Antihemophilic Factor HumanACTIVE MOIETY839MOZ74GKKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Albumin (human)INACTIVE INGREDIENTZIF514RVZRKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
AluminumINACTIVE INGREDIENTCPD4NFA903KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Calcium ChlorideINACTIVE INGREDIENTM4I0D6VV5MKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
GlycineINACTIVE INGREDIENTTE7660XO1CKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
HistidineINACTIVE INGREDIENT4QD397987EKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Tri-n-butyl PhosphateINACTIVE INGREDIENT95UAS8YAF5KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11

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 25 of 54 · 1,068 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Kidneyforce-HPARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREABioActive Nutritional, Inc.0c0f0c0c-10c2-47eb-aad6-bbffb6e167992025-04-02WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDE TABLETBelleview Bioscience LLC31195e8f-d4de-9e37-e063-6294a90a41562025-03-24WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO13 Lactose FreeCALC PHOS KALI SULPH, KALI PHOS, NAT MURBestmade Natural Products303590c5-8a66-aafc-e063-6294a90a1a4e2025-03-23WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO13CALC PHOS, KALI SULPH, KALI PHOS, NAT MURBestmade Natural Products2fffab7f-0d4b-0e96-e063-6294a90a34d82025-03-23WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Nat MurNAT MURBestmade Natural Productse9e9a4f6-5104-3c6f-e053-2995a90a11652025-03-21WarningsExact identifier
unii: 451W47IQ8X
Pituitary LiquescenceCAULOPHYLLUM THALICTROIDES, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), CIMICIFUGA RACEMOSA, NATRUM MURIATICUM, CINCHONA OFFICINALIS, ADRENOCORTICOTROPHINNutritional Specialties, Inc.292ca967-abe8-4ae1-b2fe-942531a1e14a2025-03-20WarningsExact identifier
unii: 451W47IQ8X
Anxiety HPACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), STAPHYSAGRIA, STRAMONIUMEnergique, Inc.191393fa-5f36-43c0-a183-09258eef9bda2025-03-20WarningsExact identifier
unii: 451W47IQ8X
HYDRA NEBSODIUM CHLORIDEVenture Healthcare Ltd30b184bf-2451-d96b-e063-6294a90a43c72025-03-19WarningsExact identifier
unii: 451W47IQ8X
HYDRA NEBSODIUM CHLORIDELaboratoire Unither30b244c0-84bb-a0a0-e063-6394a90a9dee2025-03-19WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO16 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products3036922b-0f2c-12ff-e063-6394a90a85782025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO20 Lactose FreeCALC FLUOR, CALC SULPH, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products30394e7e-170f-7b9d-e063-6394a90afcdb2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO27 Lactose FreeNAT MUR, KALI PHOS, CALC PHOSBestmade Natural Products303b25cc-b559-3841-e063-6294a90a398b2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28 Lactose FreeCALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products303b4d92-9f75-38a5-e063-6294a90ae93d2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Psora MiasmEGGSHELL MEMBRANE, WHEY PROTEIN, CALCAREA CARBONICA, LYCOPODIUM CLAVATUM, SULPHUR, ARSENICUM ALBUM, CROTON TIGLIUM, GRAPHITES, HYDROCOTYLE ASIATICA, NATRUM MURIATICUMEnergique, Inc.6a12aa49-35fc-41f4-bec8-6f9a20a97caa2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO4 Lactose FreeCALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Products30220aca-e052-95f3-e063-6294a90a9cea2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO5 Lactose FreeFERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Products30225814-b9d7-f16a-e063-6294a90a01942025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO6 Lactose FreeFERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products302292bd-9c38-2638-e063-6294a90a965d2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO11 Lactose FreeFERR PHOS, KALI MUR, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products3025f91f-bc0a-691c-e063-6294a90ad1362025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO12 Lactose FreeFERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Products30262ecd-5bd9-80d0-e063-6294a90ab1db2025-03-12WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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