FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Esmolol Hydrochloride - Eugia US LLC | EUGIA PHARMA SPECIALITIES LIMITEDEugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED2024-09-17Human Prescription Drug Label
esmolol hydrochloride - Eugia US LLC | Eugia Pharma Specialities LimitedEugia US LLC | Eugia Pharma Specialities Limited2023-08-04Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-421-01esmolol hydrochloride1 in 1 POUCHINJECTION16
55150-421-01esmolol hydrochloride100 mL in 1 BAGINJECTION1006
55150-421-10esmolol hydrochloride10 in 1 CARTONINJECTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-421ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION ESMOLOL HYDROCHLORIDE (ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE) INJECTION [EUGIA US LLC]6Current NDC, Legacy NDC, 3 package rows20240919_ac22475d-2d78-469f-9435-b403ac4ee380.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-421-01ML - Milliliter55150-421ba3d25e4-7591-48ea-a329-e37f552ac73e12022-07-06
55150-421-10ML - Milliliter55150-421b0fa01fa-24d0-49bd-872d-6da66c23f09f12022-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESMOLOL HYDROCHLORIDEACTIVE INGREDIENTV05260LC8DESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
ESMOLOLACTIVE MOIETYMDY902UXSRESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RESMOLOL 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 26 of 57 · 1,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BIO27 Lactose FreeNAT MUR, KALI PHOS, CALC PHOSBestmade Natural Products303b25cc-b559-3841-e063-6294a90a398b2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28 Lactose FreeCALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products303b4d92-9f75-38a5-e063-6294a90ae93d2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Psora MiasmEGGSHELL MEMBRANE, WHEY PROTEIN, CALCAREA CARBONICA, LYCOPODIUM CLAVATUM, SULPHUR, ARSENICUM ALBUM, CROTON TIGLIUM, GRAPHITES, HYDROCOTYLE ASIATICA, NATRUM MURIATICUMEnergique, Inc.6a12aa49-35fc-41f4-bec8-6f9a20a97caa2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO4 Lactose FreeCALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Products30220aca-e052-95f3-e063-6294a90a9cea2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO5 Lactose FreeFERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Products30225814-b9d7-f16a-e063-6294a90a01942025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO6 Lactose FreeFERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products302292bd-9c38-2638-e063-6294a90a965d2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO11 Lactose FreeFERR PHOS, KALI MUR, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products3025f91f-bc0a-691c-e063-6294a90ad1362025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO12 Lactose FreeFERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Products30262ecd-5bd9-80d0-e063-6294a90ab1db2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO20CALC FLUOR, CALC SULPH, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products300d4674-5c2e-01b6-e063-6294a90acbf92025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO27NAT MUR, KALI PHOS, CALC PHOSBestmade Natural Products300e8ba5-1b16-ad40-e063-6294a90a674d2025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28CALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products300ead4c-6937-d597-e063-6394a90ad6bb2025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO1 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, NAT MURBestmade Natural Products3013926f-ecd2-d376-e063-6294a90a47432025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO2 Lactose FreeKALI PHOS, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products3013d3a9-7f20-4d19-e063-6394a90a58142025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Products2ffcffd8-94ba-3a4c-e063-6394a90a24ee2025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO5FERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Products2ffd4d8f-75bf-1b9b-e063-6294a90abc362025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO6FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products2ffd93dd-1084-4b24-e063-6294a90a14332025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO11FERR PHOS, KALI MUR, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products2fff2361-a171-2249-e063-6394a90a8b652025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO12FERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Products2fff612e-16dc-dcbf-e063-6294a90a22ad2025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products30002ebe-3b38-cb35-e063-6394a90a8f7e2025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO1CALC PHOS FERR PHOS, KALI PHOS, NAT MURBestmade Natural Products2fd724b6-c6cf-652a-e063-6294a90ab4d72025-03-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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