NDC 0169-8501 - 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: 0169-8501
Package NDCs from labels: 0169-8501-11, 0169-8501-90
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
0169-8501-11	ESPEROCT	4 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	4 mL	125 [iU] in 1mL	7
0169-8501-90	ESPEROCT	4 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	4 mL	125 [iU] in 1mL	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0169-8501	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 31 of 48 · 945 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PTS/Stress Remedy	ACONITUM NAPELLUS, AMBRA GRISEA, ARGEMONE MEXICANA, ARNICA MONTANA, ARSENICUM ALBUM, BUTHUS AUSTRALIS, CACAO, CALCAREA CARBONICA, CEREBRUM SUIS, CICUTA VIROSA, GLANDULA SUPRARENALIS SUIS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, LILIUM TIGRINUM, LITHIUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, STRAMONIUM, TARENTULA HISPANA	Deseret Biologicals, Inc.	a631a250-d6d8-479c-a53e-347ac908c5ff	2024-10-22	Warnings	Exact identifier unii: 451W47IQ8X
Metox	ALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, NIOBIUM,	Deseret Biologicals, Inc.	ddaedfad-c7d1-4aeb-a52e-dce5c1b45c92	2024-10-22	Warnings	Exact identifier unii: 451W47IQ8X unii: AE28F7PNPL
Rhustoxoforce	APIS MELLIFICA, CANTHARIS, GRAPHITES, NATRUM MURIATICUM, RHUS GLABRA, RHUS TOXICODENDRON, RHUS VENENATA, URTICA DIOICA	BioActive Nutritional, Inc.	5a3627f1-a850-42f3-8c7a-b2067bd03538	2024-10-18	Warnings	Exact identifier unii: 451W47IQ8X
LACTATED RINGERS	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Becton Dickinson and Company	bb2ad9cd-5d9a-4337-be61-0842d738c79e	2024-10-16	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
Elliotts B	SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE	Lukare Medical, LLC	08036dbd-55b3-47b9-9890-000f253544f3	2024-10-16	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
LACTATED RINGERS	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Fresenius Kabi USA, LLC	8fce1477-991f-4b43-bf05-a80bad897262	2024-10-16	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	c44b0fdb-33df-4747-b443-5fb4deb456cb	2024-10-11	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Bacteriostatic Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	e5e325d1-0d58-40c9-9645-3ae402ff9d92	2024-10-11	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Vamousse Lice Defense	EUCALYPTUS GLOBULUS, NATRUM MURIATICUM	Alliance Pharma Inc.	c87ce5d3-c200-421e-88be-bc8060a5993a	2024-10-08	Warnings	Exact identifier unii: 451W47IQ8X
Energy Catalyst	VISCUM ALBUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERROUS FUMARATE, MAGNESIUM ASPARTATE, MANGANESE GLUCONATE, PHOSPHORUS, POTASSIUM ASPARTATE, SODIUM MOLYBDATE, ADENOSINUM, CYCLOPHOSPHORICUM, CERIUM OXALICUM, NICKEL ACETATE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, CESIUM CHLORIDE, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, ALUMINA,	Deseret Biologicals, Inc.	99529dd4-f8ab-4348-8b65-dc8c89e1ad54	2024-10-04	Warnings	Exact identifier unii: 451W47IQ8X
Thyroid HP	BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA IODATA, FUCUS VESICULOSUS, IODIUM, LAPIS ALBUS, LEVOTHYROXINUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SELENIUM METALLICUM, SPONGIA TOSTA, THYROIDINUM (SUIS)	Energique, Inc.	2f04e425-7160-41a7-aa1e-934db54f1751	2024-09-30	Warnings	Exact identifier unii: 451W47IQ8X
Gut Brain Spectrum	ABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUM	Energique, Inc.	cb1566a4-92d4-4f1a-9211-f0c538a83c27	2024-09-27	Warnings	Exact identifier unii: C151H8M554 unii: 451W47IQ8X
Muro 128	SODIUM CHLORIDE	Bausch & Lomb Incorporated	cc3d5bc8-9d3c-4c65-9e43-707a2db4081a	2024-09-25	Warnings	Exact identifier unii: 451W47IQ8X
Muro 128	SODIUM CHLORIDE	Bausch & Lomb Incorporated	93fafa27-5031-4d95-b4b8-5574b7204ae2	2024-09-25	Warnings	Exact identifier unii: 451W47IQ8X
Muro 128	SODIUM CHLORIDE	Bausch & Lomb Incorporated	454f337e-d897-46de-ab05-1c543a33061c	2024-09-25	Warnings	Exact identifier unii: 451W47IQ8X
Defense	PETROSELINUM SATIVUM, NATRUM MURIATICUM, HEPAR (BOVINE), MEDULLA OSSIS SUIS, SPLEEN (BOVINE), THYMUS (OVINE), SACCHARINUM	Nutritional Specialties, Inc.	ddd879cf-1a85-4b8d-bdb0-5cf495fea4e6	2024-09-24	Warnings	Exact identifier unii: 451W47IQ8X
HP Axis	ARGENTUM NITRICUM, BERBERIS VULGARIS, IODIUM, KALI CARBONICUM, NATRUM MURIATICUM, ADRENALINUM, CORTISONE ACETICUM, DHEA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, MELATONIN, TESTOSTERONE, ARSENICUM ALBUM, PHOSPHORUS, PROTEUS (VULGARIS), SEPIA, SILICEA, ALLOXANUM, CORTICOTROPIN RELEASING HORMONE, ADRENOCORTICOTROPHIN, ALDOSTERONE	Deseret Biologicals, Inc.	402f5b05-c71e-4dba-bc2b-049aee42952a	2024-09-23	Warnings	Exact identifier unii: 451W47IQ8X
PMS Relief	AGNUS CASTUS, AURUM SULPHURATUM, CANDIDA ALBICANS, CIMICIFUGA RACEMOSA, COCCULUS INDICUS, CONIUM MACULATUM, CYCLAMEN EUROPAEUM, ELAPS CORALLINUS, FOLLICULINUM, HYPOTHALAMUS SUIS, KALI CARBONICUM, LAC CANINUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, PULSATILLA (PRATENSIS), SACCHARUM OFFICINALE, STANNUM METALLICUM, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)	Deseret Biologicals, Inc.	f03d8463-0a6d-4577-8fba-9cba246d3d45	2024-09-23	Warnings	Exact identifier unii: C151H8M554
Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	Fresenius Kabi USA, LLC	3c5f0f65-8a54-4a55-ad4e-0f0be97631d7	2024-09-15	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Thyroid HP	BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA IODATA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SPONGIA TOSTA, THYROIDINUM (SUIS)	Energique, Inc.	3a4f9647-a4d9-4bca-96d1-ec717f938d4a	2024-09-11	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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