NDC 0169-8301 - 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: 0169-8301
Package NDCs from labels: 0169-8301-11, 0169-8301-90
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
0169-8301-11	ESPEROCT	4 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	4 mL	750 [iU] in 1mL	7
0169-8301-90	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
0169-8301	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 29 of 48 · 945 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mast Cell Pro	HYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM,	Energique, Inc.	5cd31e1d-0312-48d1-9ecd-d01c6fe3b672	2024-12-11	Warnings	Exact identifier unii: 451W47IQ8X
Junior Moves	ANACARDIUM, BRYONIA, MAG MUR, NAT MUR, PLUMB MET	Silver Star Brands	822d5481-7854-3fe7-e053-2a91aa0abf55	2024-12-03	Warnings	Exact identifier unii: 451W47IQ8X
Migo-Ease	ACONITUM NAP, LYCOPODIUM, NAT MUR, NUX VOM, PULSATILLA	Silver Star Brands	816837f5-4487-657d-e053-2991aa0a78f4	2024-12-03	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Company	464c2d78-5c88-4668-a039-56dd3c1c9b20	2024-12-03		Exact identifier unii: 451W47IQ8X
XX Health Pro	LACHESIS, NAT MUR, PULSATILLA, SEPIA, SULPHUR	Silver Star Brands	4d11a65e-696a-0727-e054-00144ff88e88	2024-12-02	Warnings	Exact identifier unii: 451W47IQ8X
Para-Si	JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER	Newton Laboratories, Inc.	27d41602-9dcb-eaa8-e063-6394a90a7cfa	2024-11-26	Warnings	Exact identifier unii: 451W47IQ8X
Para-Si	JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER	Newton Laboratories, Inc.	27d4ddaf-9c07-a7fc-e063-6394a90adc0b	2024-11-26	Warnings	Exact identifier unii: 451W47IQ8X
Para-Si	JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER	Newton Laboratories, Inc.	27d5997b-1cae-41c2-e063-6394a90ac74a	2024-11-26	Warnings	Exact identifier unii: 451W47IQ8X
ReHydration	ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUM	Energetix Corporation	37063a49-6b45-4167-875d-49c9dac3f79b	2024-11-20	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Company	99a15716-bbb9-4e33-a48d-20c58b81f392	2024-11-13		Exact identifier unii: 451W47IQ8X
Focus	ADENOSINUM CYCLOPHOSPHORICUM, ADRENALINUM, AETHUSA CYNAPIUM, ALPHA-KETOGLUTARICUM ACIDUM, AMBRA GRISEA, BARYTA CARBONICA, CANDIDA ALBICANS, CARBONEUM SULPHURATUM, CEREBRUM SUIS, GINKGO BILOBA, HELLEBORUS NIGER, HYPOTHALAMUS SUIS, HYOSCYAMUS NIGER, IODIUM, PHOSPHORUS, SACCHARUM OFFICINALE, SARCOLACTICUM ACID, SILICEA, TARENTULA HISPANA, VERATRUM ALBUM	Deseret Biologicals, Inc.	e014e6b6-a07a-4170-b9af-f477da71597d	2024-11-13	Warnings	Exact identifier unii: C151H8M554
Itch Formula	ANTIPYRINUM, APIS MELLIFICA, CALENDULA OFFICINALIS, CANTHARIS, COPAIVA OFFICINALIS, CROTON TIGLIUM, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, MEZEREUM, NATRUM MURIATICUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, SULPHUR, URTICA URENS	Deseret Biologicals, Inc.	4dfb177b-bff3-4b6d-8fd9-cadd1df7812c	2024-11-12	Warnings	Exact identifier unii: 451W47IQ8X
Plasma-Lyte 148 (pH 7.4)	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE	Baxter Healthcare Corporation	fe935c8d-f42d-42e4-8665-0dc66829f231	2024-11-08		Exact identifier unii: 451W47IQ8X
Calcium Chloride	CALCIUM CHLORIDE	Civica, Inc.	7fa5d8e8-0610-4892-907e-5ef630a56e76	2024-11-08	Warnings, Adverse reactions	Exact identifier unii: M4I0D6VV5M
Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	BECTON DICKINSON AND COMPANY	d3f90d2f-4536-4d32-800b-7a798f8a35db	2024-11-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Hospira, Inc.	8eb172da-dcd4-4660-4a8f-ad44a14b4af7	2024-11-06	Adverse reactions	Exact identifier unii: 451W47IQ8X
Licefreee Everyday	SODIUM CHLORIDE	Tec Laboratories,Inc.	407b5fd6-2331-2ba7-e054-00144ff88e88	2024-11-05	Warnings	Exact identifier unii: 451W47IQ8X
Licefreee	HEAD LICE TREATMENT	Tec Laboratories, Inc.	08c9d3dd-7177-0148-e054-00144ff8d46c	2024-11-05	Warnings	Exact identifier unii: 451W47IQ8X
Bladder Relief	CAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS	Magni Company	5d0db70c-6360-493b-bcf2-8dbc95314140	2024-11-05	Warnings	Exact identifier unii: 451W47IQ8X
Vaccines	ARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MORBILLINUM, NATRUM MURIATICUM, SILICEA, SULPHUR IODATUM, THUJA OCCIDENTALIS, URTICA URENS	Liddell Laboratories, Inc.	6e6e67d4-089e-4775-b4a4-5511953f6e3f	2024-11-04	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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