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
Label	Manufacturer	Effective date	Type
Koate - KEDRION BIOPHARMA, INC. \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	KEDRION BIOPHARMA, INC. \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	2023-12-13	PLASMA DERIVATIVE
Koate - KEDRION BIOPHARMA, INC. \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	KEDRION BIOPHARMA, INC. \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	2023-12-12	PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76125-252-21	Koate	5 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	5 mL	250 [iU] in 5mL	23
76125-252-21	Koate	5 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	5 mL	250 [iU] in 5mL	23
76125-252-21	Koate	5 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	5 mL	250 [iU] in 5mL	23
76125-252-21	Koate	5 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	5 mL	250 [iU] in 5mL	10
76125-252-21	Koate	5 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	5 mL	250 [iU] in 5mL	10
76125-252-21	Koate	5 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	5 mL	250 [iU] in 5mL	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76125-252	KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.]	23	Unmatched	20231228_2f77d685-e382-b2e7-2414-0d3a3448688a.zip
76125-252	KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.]	10	Unmatched	20231228_865df1e2-b4d1-dbf5-2899-a9c02df4d122.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Antihemophilic Factor Human	ACTIVE INGREDIENT	839MOZ74GK	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Antihemophilic Factor Human	ACTIVE MOIETY	839MOZ74GK	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Albumin (human)	INACTIVE INGREDIENT	ZIF514RVZR	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Aluminum	INACTIVE INGREDIENT	CPD4NFA903	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Calcium Chloride	INACTIVE INGREDIENT	M4I0D6VV5M	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Glycine	INACTIVE INGREDIENT	TE7660XO1C	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Histidine	INACTIVE INGREDIENT	4QD397987E	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Tri-n-butyl Phosphate	INACTIVE INGREDIENT	95UAS8YAF5	KOATE -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 7 of 54 · 1,068 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quantum Resonance	ALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUM	Deseret Biologicals, Inc.	1467111a-bef6-473d-b7f2-3309a9bb72ce	2026-04-10	Warnings	Exact identifier unii: 451W47IQ8X
H-Focus Formula	AGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUM	Healing Natural Oils LLC	4ee42911-3064-7f55-e063-6294a90abcc7	2026-04-07	Warnings	Exact identifier unii: 451W47IQ8X
H-Mood Formula	AGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUM	Healing Natural Oils LLC	4ee5c82e-9edf-c36e-e063-6394a90a237f	2026-04-07	Warnings	Exact identifier unii: 451W47IQ8X
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye	SODIUM CHLORIDE	Walgreen Company	bda3b9db-5fc4-408c-a5ae-d1eeb3ee308d	2026-04-06	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye	SODIUM CHLORIDE	Hanlim	4ee80e16-1bb1-8238-e063-6294a90aa719	2026-04-04	Warnings	Exact identifier unii: 451W47IQ8X
KIDS TOOTHPASTE, FOR CAVITY PROTECTION	KIDS TOOTHPASTE FOR CAVITY PROTECTION	Shulisa (Foshan) Daily ChemicalIndustry Co., Ltd	4e8fab9e-f05c-5e2f-e063-6294a90aecf9	2026-04-03	Warnings	Exact identifier unii: 059QF0KO0R
BACTERIOSTATIC SODIUM CHLORIDE	SODIUM CHLORIDE	Hospira, Inc.	376093e7-e09e-4a57-3199-195e45251866	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Migraine and Headache	IRIS VERSICOLOR ROOT AND SODIUM CHLORIDE	Forces of Nature	0dd2f2e2-78e2-435e-b7b2-ca590953ff94	2026-04-01	Warnings	Exact identifier unii: 451W47IQ8X
Cold Sore Formula	DULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM MURIATICUM, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODE	Nutritional Specialties, Inc.	f4e7e469-baaf-4c61-af44-80b0832eadf0	2026-03-31	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride Normal Salt	SODIUM CHLORIDE	TWIN MED LLC	10230c8a-e5e5-44f1-b41d-80930899d6b9	2026-03-31	Warnings	Exact identifier unii: 451W47IQ8X
H-Allergy Formula	ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARUM TRIPHYLLUM, ARUNDO MAURITANICA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, NATRUM MURIATICUM, SOLIDAGO VIRGAUREA, STICTA PULMONARIA, SULPHUR, TRIFOLIUM PRATENSE, WYETHIA HELENIOIDES	Healing Natural Oils LLC	4e586360-b3c4-1ce0-e063-6394a90ab6b8	2026-03-31	Warnings	Exact identifier unii: 451W47IQ8X
Acne HP	CARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUM	BioActive Nutritional, Inc.	2ab4ff53-4274-40c7-b05c-44d918d809be	2026-03-31	Warnings	Exact identifier unii: 451W47IQ8X
Cold Sore Formula	DULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM HYPOCHLOROUS, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODE	Nutritional Specialties, Inc.	ad6a08ec-5eba-405b-8a07-79ac86ab3e7a	2026-03-31	Warnings	Exact identifier unii: 451W47IQ8X
ANX HP	ARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM	BioActive Nutritional, Inc.	96035891-aea3-4138-bb26-801ad819f639	2026-03-30	Warnings	Exact identifier unii: 451W47IQ8X
Spleen Liquescence	QUERCUS ROBUR, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), NATRUM MURIATICUM, HELIANTHUS ANNUUS	Nutritional Specialties, Inc.	d800456d-60f0-413d-b310-91b8b881f6b9	2026-03-30	Warnings	Exact identifier unii: 451W47IQ8X
Depressoforce	PICRICUM ACIDUM, ARSENICUM ALBUM, AURUM METALLICUM, IGNATIA AMARA, NATRUM MURIATICUM, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SEPIA	BioActive Nutritional, Inc.	e6b98979-a38c-4f13-af03-f5ffa962b4fa	2026-03-27	Warnings	Exact identifier unii: 451W47IQ8X
Adrenapar	ARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUM	Energique, Inc.	077a9171-283d-47b6-bddc-34c739f6d69d	2026-03-27	Warnings	Exact identifier unii: 451W47IQ8X
Buffer pH	CHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIA	NaturalCare	2161a2e2-613d-4dac-a5f6-796d40e849d9	2026-03-25	Warnings	Exact identifier unii: 451W47IQ8X
Reflux Away	ABIES NIGRA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLOCYNTHIS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA	NaturalCare	8a00a72f-60df-4477-b7b8-abb6355e34da	2026-03-24	Warnings	Exact identifier unii: 451W47IQ8X
Worafy Gentle Eye Wash	SODIUM CHLORIDE	Shenzhen Shandian Jingling Technology Co., Ltd.	4da864dc-e10c-1db9-e063-6394a90a0984	2026-03-22	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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