NDC 55150-421-01 - Esmolol Hydrochloride

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: 55150-421
Requested NDC: 55150-421-01
Package NDCs from labels: 55150-421-01, 55150-421-10
Manufacturer: Eugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED
Effective date: 2024-09-17
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Esmolol Hydrochloride - Eugia US LLC \| EUGIA PHARMA SPECIALITIES LIMITED	Eugia US LLC \| EUGIA PHARMA SPECIALITIES LIMITED	2024-09-17	Human Prescription Drug Label
esmolol hydrochloride - Eugia US LLC \| Eugia Pharma Specialities Limited	Eugia US LLC \| Eugia Pharma Specialities Limited	2023-08-04	Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55150-421-01	esmolol hydrochloride	1 in 1 POUCH	INJECTION	1	6
55150-421-01	esmolol hydrochloride	100 mL in 1 BAG	INJECTION	100	6
55150-421-10	esmolol hydrochloride	10 in 1 CARTON	INJECTION	10	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55150-421	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION ESMOLOL HYDROCHLORIDE (ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE) INJECTION [EUGIA US LLC]	6	Current NDC, Legacy NDC, 3 package rows	20240919_ac22475d-2d78-469f-9435-b403ac4ee380.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55150-421-01	ML - Milliliter	55150-421	ba3d25e4-7591-48ea-a329-e37f552ac73e	1	2022-07-06
55150-421-10	ML - Milliliter	55150-421	b0fa01fa-24d0-49bd-872d-6da66c23f09f	1	2022-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESMOLOL HYDROCHLORIDE	ACTIVE INGREDIENT	V05260LC8D	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	1
ESMOLOL	ACTIVE MOIETY	MDY902UXSR	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	1
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	1

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 46 of 57 · 1,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ringers	SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	b53c598c-dc7d-4a15-9319-8edf265e7b42	2023-08-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Anubis Barcelona Vital Line	HYDROLYZED COLLAGEN	ANUBIS COSMETICS SL	f564bbf0-3b5c-4a81-e053-2a95a90a7ea6	2023-08-29	Warnings	Exact identifier unii: 059QF0KO0R
Pancreapar	SYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUM	Energique, Inc.	99a4560e-f124-4569-a2f1-78ce5995f8e0	2023-08-24	Warnings	Exact identifier unii: Q40Q9N063P
Pancreapar	SYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUM	Energique, Inc.	ba9c13d0-92de-4159-8a35-215e3de50c07	2023-08-24	Warnings	Exact identifier unii: Q40Q9N063P
Acetic Acid	ACETIC ACID	B. Braun Medical Inc.	dd45cee3-9938-4dad-a5e1-1dd4baea85a9	2023-08-23	Warnings, Adverse reactions	Exact identifier unii: Q40Q9N063P
BABY MUCUS PLUS COLD RELIEF	BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE	Hyland's Inc.	d934cc8a-1e43-4942-858a-05b5d068679a	2023-08-22	Warnings	Exact identifier unii: 451W47IQ8X
Hepaticol Sarcode	CARDUUS MARIANUS, ZINGIBER OFFICINALE, BERBERIS VULGARIS, CHELIDONIUM MAJUS, MAGNESIA MURIATICA, LEPTANDRA VIRGINICA, NATRUM MURIATICUM, BRYONIA (ALBA), HEPAR (BOVINE), NATRUM SULPHURICUM, ATROPINUM SULPHURICUM, LYCOPODIUM CLAVATUM	Nutritional Specialties, Inc.	f9d95b2f-53d9-4017-873f-5ad0b129f9f8	2023-08-14	Warnings	Exact identifier unii: 451W47IQ8X
Cellergy	CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA.	Ratis, LLC	2aebc11e-eeb7-436b-b90c-3a2f59fb7492	2023-08-07	Warnings	Exact identifier unii: 451W47IQ8X
b6fe7379-bb70-414a-9f92-bba99036ff05			3e72bb62-3680-4646-973d-a40f025e9c1c	2023-08-04	Warnings, Adverse reactions	Exact identifier spl id: b6fe7379-bb70-414a-9f92-bba99036ff05 spl set id: 3e72bb62-3680-4646-973d-a40f025e9c1c
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	017f3bcf-0e45-d390-e063-6394a90a588e	2023-07-28	Warnings	Exact identifier unii: 451W47IQ8X
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	017f0210-195d-11d7-e063-6294a90aa750	2023-07-27	Warnings	Exact identifier unii: 451W47IQ8X
Melatonin Pro	CALCAREA CARBONICA, CHAMOMILLA, COCCULUS INDICUS, COFFEA CRUDA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA CARBONICA, MELATONIN, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS)	Energique, Inc.	1f374642-83f7-4e64-b330-0f6ef21000a9	2023-07-19	Warnings	Exact identifier unii: 451W47IQ8X
Gum Therapy	CALENDULA OFFICINALIS, KALI PHOSPHORICUM, NATRUM MURIATICUM, ARNICA MONTANA, AGAVE AMERICANA, CISTUS CANADENSIS, KREOSOTUM, MYRRHA, CALCAREA FLUORICA, ACONITUM NAPELLUS, BISMUTHUM SUBNITRICUM, SEPIA, HEPAR SULPHURIS CALCAREUM, MERCURIUS VIVUS	Deseret Biologicals	0cf8a815-808d-4018-baf9-2b4545fc7ea8	2023-07-19	Warnings	Exact identifier unii: 451W47IQ8X
REFL HS	ADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREATINUM, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)	Deseret Biologicals, Inc.	2fe2d3c1-1829-4a33-be8e-2bad52546f36	2023-07-17	Warnings	Exact identifier unii: QTT17582CB
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	b6e33138-841a-471f-a934-c4086cbc23f6	2023-07-17	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Anpituapar	HYPOPHYSIS SUIS, AGNUS CASTUS, BARYTA CARBONICA, CALCAREA CARBONICA, IODIUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SEPIA, THYROIDINUM (SUIS), LAC CANINUM, ADRENOCORTICOTROPHIN	Energique, Inc.	c0ed2996-8eb5-43f7-b3cc-17477af7f7e9	2023-07-13	Warnings	Exact identifier unii: 451W47IQ8X
Pneumotox	TRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,	BioActive Nutritional, Inc.	f8846fb1-92e5-4f8e-b3b3-bc620df90a62	2023-07-12	Warnings	Exact identifier unii: 451W47IQ8X
esmolol hydrochloride	ESMOLOL HYDROCHLORIDE	Sagent Pharmaceuticals	f12fb0fd-fa05-49fc-b5e3-a2050b816ef2	2023-07-12	Warnings, Adverse reactions	Exact identifier rxcui: 979432 rxcui: 1736541 unii: V05260LC8D
Thyrostat	FUCUS VESICULOSUS, SPONGIA TOSTA, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), ARSENICUM IODATUM, BARYTA CARBONICA, IODIUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM	Energique, Inc.	5c41b36c-e28f-4d60-b9b9-6b888d55ea95	2023-07-12	Warnings	Exact identifier unii: 451W47IQ8X
Introvert Formula	PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), IGNATIA AMARA, NATRUM MURIATICUM, DUODENUM (SUIS), PETROLEUM, SULPHUR	Nutritional Specialties, Inc.	522148c9-0bc0-44c9-8876-70051224c951	2023-07-11	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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