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#

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 39 of 54 · 1,068 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PTS/Stress RemedyKALI PHOSPHORICUM, AMBRA GRISEA, CACAO, PHOSPHORICUM ACIDUM, ARNICA MONTANA, CALCAREA CARBONICA, CEREBRUM SUIS, GLANDULA SUPRARENALIS SUIS, LITHIUM CARBONICUM, ACONITUM NAPELLUS, ARGEMONE MEXICANA, ARSENICUM ALBUM, CICUTA VIROSA, HYOSCYAMUS NIGER, IGNATIA TIGRINUM, NATRUM MURIATICUM, TARENTULA HISPANICA, STRAMONIUM, BUTHUS AUSTRALISDeseret Biologicals, Inc.05341147-789a-4844-9412-6a3044e5eb182024-03-04WarningsExact identifier
unii: 451W47IQ8X
Calcium ChlorideCALCIUM CHLORIDEInternational Medication Systems, Limited8295039b-2559-4626-90c8-6ac7e896e41a2024-03-01Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
EPST PLUSCARDUUS MARIANUS, CISTUS CANADENSIS, DULCAMARA, GALIUM APARINE, MAGNESIA MURIATICA, NATRUM SULPHURICUM, VISCUM ALBUM, MURIATICUM ACIDUM, FOLLICULINUM, AQUA MARINA, AILANTHUS GLANDULOSUS, BARYTA MURIATICA, CADMIUM METALLICUM, CEANOTHUS AMERICANUS, COCCULUS INDICUS, IRIDIUM METALLICUM, THUJA OCCIDENTALIS, CINCHONA OFFICINALIS, CALCAREA CARBONICA, CROTALUS CASCAVELLADeseret Biologicals, Inc.c2bb50a8-e4f9-4af4-aefc-53c9c3cfcc252024-02-27WarningsExact identifier
unii: 451W47IQ8X
CALCIUM CHLORIDECALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta9500f41-8041-d753-e053-2a95a90a6f3c2024-02-26Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Bladder ReliefCAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISThe Magni Companyb09bf037-703f-4c22-8535-b33d586ebefa2024-02-08WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Natrum MuriaticumSODIUM CHLORIDESEVENE USA11008014-fff6-4d5a-8c5c-a20443d7cc232024-01-30WarningsExact identifier
unii: 451W47IQ8X
CALCIUM CHLORIDECALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst75c43df8-24f4-7f26-e053-2a91aa0aa21b2024-01-29Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta14ca7d9-de30-a303-e053-2a95a90a53042024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirste5247ed5-6170-c13f-e053-2a95a90a41012024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CALCIUM CHLORIDECALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst994a17da-4430-9489-e053-2a95a90acb7c2024-01-27Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea2024-01-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
CIRCULATION HPARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, LACHESIS MUTUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREA,Energique, Inc.464d208b-3893-4ec6-9868-12ef6807b98d2024-01-23WarningsExact identifier
unii: 451W47IQ8X
DERMA SCALE HPARSENICUM IODATUM, BORAX, GRAPHITES, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PETROLEUM, SEPIA, SULPHUREnergique, Inc.64961787-7e9a-4e6f-98ce-0f51934155cf2024-01-23WarningsExact identifier
unii: 451W47IQ8X
Energy ComplexECHINACEA (ANGUSTIFOLIA), LAPPA MAJOR, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ADRENALINUM, ALOE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, BRYONIA (ALBA), CHELIDONIUM MAJUS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, FERRUM METALLICUM, GLONOINUM, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, IODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, RHUS TOX, RUTA GRAVEOLENS, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Health Masters LLC9286ca29-8190-4867-9231-b0d68180cb102024-01-22WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDESpectra Medical Deviecs, LLC7e316d21-d6ad-4976-bd90-268fd7e513612024-01-12Adverse reactionsExact identifier
unii: 451W47IQ8X
A01 CELLULAR RECHARGEACETICUM ACIDUM, ARNICA MONTANA, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CEANOTHUS AMERICANUS, CERATOSTIGMA ILLMOTTIANUM, CHININUM ARSENICOSUM, CITRICUM ACIDUM, ENGLISH ELM, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, HYDROFLUORICUM ACIDUM, JUGLANS REGIA, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SILICOFLUORICUM, NATRUM SULPHURICUM, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREAApex Energetics Inc.b932ebd3-afea-6a95-e053-2995a90a27352024-01-08WarningsExact identifier
unii: 451W47IQ8X
A12 DTX-KIDNEYAPIS MELLIFICA, BERBERIS VULGARIS, BETULA PUBESCENS BARK, BETULA VERRUCOSA LEAF, BOS TAURUS KIDNEY, BOS TAURUS URINARY BLADDER, CITRICUM ACIDUM, CITRUS LIMONUM, FAGUS SYLVESTRIS FLOWER BUD, NATRUM MURIATICUM, PETROSELINUM SATIVUM, QUERCUS ROBUR FLOWER BUD, SINUSITISINUM, SOLIDAGO VIRGAUREAApex Energetics Inc.bf52e26f-aa27-87ca-e053-2995a90a23e72024-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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