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 51 of 57 · 1,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Saline Kids Mist PediaMeds	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC.	e5c5b580-1d9f-3081-e053-2995a90a8031	2022-08-08	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Saline Kids Mist SinuCleanse Breathe	SODIUM CHLORIDE	ASCENT CONSUMER PRODUCTS, INC.	e5c5c313-046f-b0a7-e053-2a95a90a2a07	2022-08-08	Warnings	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	123bd10a-90c7-499e-97f6-acf7e0f0fb4e	2022-07-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Herplex	ANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIA	Nashco Products LLC	fad9615f-7004-415d-9f69-ee9ff95f0067	2022-07-12	Warnings	Exact identifier unii: 451W47IQ8X
BHI Constipation	DIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEED	MediNatura Inc	0365b75b-fee4-4c1d-89ab-c692bdd73f75	2022-07-07	Warnings	Exact identifier unii: 451W47IQ8X
Natrium Muriaticum 6X	SODIUM CHLORIDE	Seroyal USA	0ebf18de-12fe-0bc4-e054-00144ff88e88	2022-07-07	Warnings	Exact identifier unii: 451W47IQ8X
Erogetone	ARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA	Energique, Inc.	1e872ecd-e7a5-463d-9832-47b7046096db	2022-06-28	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Cardioplegic Solution	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE	Fresenius Kabi, USA, LLC	eb360dc4-88d6-4b28-9b61-bc359e16bd22	2022-05-27	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Bio Co-Enzyme Phase	BETA VULGARIS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,	Deseret Biologicals, Inc.	e8f6e2ec-ae2e-4bee-b9d3-5f3a2e3daf65	2022-05-09	Warnings	Exact identifier unii: Q40Q9N063P
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	24a08a93-df23-474b-873e-c59ec8855f9f	2022-03-14	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Wild Horse 777 Moisturizing Nasal	SODIUM CHLORIDE	Wild Horse 777, Inc.	b0b4dadd-11fa-3dbb-e053-2995a90a2097	2022-03-14	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	cc14fafd-3dcd-4fc8-bdbd-6f355c375768	2022-02-23	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	8b44bfd3-70a4-4b47-bc7b-590f63b8cc75	2022-02-15	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
ACNE HP	CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC	Natural Creations, Inc.	b2368ab6-e233-4473-99fa-86e1fbc2a879	2022-02-14	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	f62481fd-fcdb-4be6-ac13-29c590e925c3	2022-02-10	Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	e44c41ae-c9c8-4dd8-ba6c-cebb585378aa	2022-01-31	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Saline Mist Walgreens	SODIUM CHLORIDE	WALGREEN COMPANY	d6b9d4fc-b758-be32-e053-2995a90a2523	2022-01-29	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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