NDC 0169-8401 - ESPEROCT

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: 0169-8401
Package NDCs from labels: 0169-8401-11
Manufacturer: Novo Nordisk | Vetter Pharma Fertigung GmbH & Co. KG
Effective date: 2024-07-01
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ESPEROCT - Novo Nordisk \| Vetter Pharma Fertigung GmbH & Co. KG	Novo Nordisk \| Vetter Pharma Fertigung GmbH & Co. KG	2024-07-01	PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0169-8401-11	ESPEROCT	4 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	4 mL	750 [iU] in 1mL	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0169-8401	ESPEROCT (ANTIHEMOPHILIC FACTOR (RECOMBINANT), GLYCOPEGYLATED-EXEI) KIT [NOVO NORDISK]	7	Unmatched	20240726_562f94e8-825f-4d7f-b93c-b783ac3a43bc.zip

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 44 of 48 · 945 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
InterSol	PLATELET ADDITIVE 3	Fenwal, Inc.	e4f06c0b-7cb1-49c9-97a4-2cfc21298495	2021-11-16	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
CONSTIPATION CP	ALUMINUM OXIDE, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, GRAPHITE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SULFUR, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, LEAD, SEPIA OFFICINALIS JUICE.	Natural Creations, Inc.	961b3ddf-41fe-46ed-b5e4-0fd8d9652edf	2021-11-15	Warnings	Exact identifier unii: 451W47IQ8X
CENTROCODE	AMERICAN GINSENG, ADENOSINE TRIPHOSPHATE, CORTICOTROPIN, ALFALFA, BOS TAURUS HYPOTHALAMUS, PHYTOLACCA AMERICANA ROOT, BOS TAURUS PITUITARY GLAND POSTERIOR, THYROID UNSPECIFIED, IODINE, SILICON DIOXIDE, OSTER SHELL CALCIUM CARBONATE CRUDE, STRYCHNOS IGNATII SEED, IRIDIUM, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, SELENIUM, URANYL NITRATE HEXAHYDRATE.	Natural Creations, Inc.	e5bbe9ec-7602-4de5-907a-7047c10198b6	2021-11-15	Warnings	Exact identifier unii: 451W47IQ8X
OHM-ANX	ARGENTUM NITRICUM, AURUM METALLICUM, AVENA SATIVA, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, MOSCHUS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, STANNUM METALLICUM, VALERIANA OFFICINALIS	OHM PHARMA INC.	f743b690-8f79-4e60-81cd-e3e2825a1ec8	2021-11-15	Warnings	Exact identifier unii: 451W47IQ8X
Hydrate 2	BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA	Natural Creations, Inc	52cb98dc-6858-42bf-9c54-d20fb607dfbb	2021-11-12	Warnings	Exact identifier unii: 451W47IQ8X
Adrenal and DHEA	ARALIA QUINQUEFOLIA, ASHWAGANDHA, AVENA SATIVA, CARDUUS MARIANUS, DHEA, GLANDULA SUPRARENALIS SUIS, L-ARGININE, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, RHODIOLA.	ProBLEN	44991952-c440-4a33-9423-a9369c8bab70	2021-10-22	Warnings	Exact identifier unii: 451W47IQ8X
Dr. Talbots Daily Allergy Relief	ALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUM	Talbot's Pharmaceuticals Family Products, LLC.	91c2795d-4cde-6e2c-e053-2995a90a0096	2021-10-05	Warnings	Exact identifier unii: 451W47IQ8X
Solucion InterSol	SOLUCION ADITIVA PARA PLAQUETAS 3	Fenwal, Inc.	d5eaf5f4-67d3-4475-af9a-f5b0f882f5d1	2021-10-04	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
NATRUM MURIATICUM	NATRUM MURIATICUM	Rxhomeo Private Limited d.b.a. Rxhomeo, Inc	520edb18-5f2a-4448-ba53-83408a839e1f	2021-09-02	Warnings	Exact identifier unii: 451W47IQ8X
Lactated Ringers Irrigation	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE	B. Braun Medical Inc.	0db56c7a-2b8f-4593-8591-2c481c92b2cf	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
Sodium Chloride for Irrigation	SODIUM CHLORIDE FOR IRRIGATION	B. Braun Medical Inc.	5bd9b176-0402-4a3f-a6b4-c3f393fc092a	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
0.9% SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c755e41b-acba-7234-e053-2995a90aff0f	2021-07-17	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Melange combination	CALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEA	Seroyal USA	0a071fbf-0075-4479-e054-00144ff8d46c	2021-07-14	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	4a655cde-283f-4ec8-a3d9-5f539c55c204	2021-05-10	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ed8fd0c1-ac42-4267-877e-ceadf3831c90	2021-04-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dr. Talbots Vital 12	CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUC	Talbot's Pharmaceuticals Family Products, LLC	c10bb804-8169-63da-e053-2a95a90a8306	2021-04-28	Warnings	Exact identifier unii: 451W47IQ8X
Dr. Talbots Infant Daily Allergy Relief	ALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUM	Talbot's Pharmaceuticals Family Products, LLC	c0963200-67dd-6349-e053-2a95a90adde1	2021-04-22	Warnings	Exact identifier unii: 451W47IQ8X
CLINIMIX E	LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE	Baxter Healthcare Company	8469d6fb-d6ef-476f-8cc3-0905192de0a8	2021-04-13	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: 4QD397987E unii: AE28F7PNPL unii: M4I0D6VV5M
CLINIMIX	LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSE	Baxter Healthcare Corporation	dccff103-8695-400c-a15d-cc2fd078760a	2021-04-13	Warnings, Adverse reactions	Exact identifier unii: 4QD397987E unii: AE28F7PNPL
Sodium Chloride	SODIUM CHLORIDE	Medical Purchasing Solutions, LLC	c3f8e83c-4fb9-91da-e053-2a95a90abd63	2021-04-12	Adverse reactions	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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