FDA.reportPublic FDA data

NDC 67457-182-00 - 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
67457-182
Requested NDC
67457-182-00
Package NDCs from labels
67457-182-00, 67457-182-10
Manufacturer
Henry Schein, Inc.
Effective date
2025-06-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Esmolol Hydrochloride - Henry Schein, Inc.Henry Schein, Inc.2025-06-18HUMAN PRESCRIPTION DRUG LABEL
Esmolol Hydrochloride - Mylan Institutional LLCMylan Institutional LLC2025-02-27HUMAN PRESCRIPTION DRUG LABEL
ESMOLOL HYDROCHLORIDE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-02-19HUMAN PRESCRIPTION DRUG LABEL
Esmolol Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2019-12-05HUMAN PRESCRIPTION DRUG LABEL
ESMOLOL HYDROCHLORIDE - General Injectables and Vaccines, Inc.General Injectables and Vaccines, Inc.2019-08-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-182-00Esmolol Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION1011
67457-182-10Esmolol Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-182ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]11Current NDC, Legacy NDC, 2 package rows20250522_94f069f9-dd52-4a69-a103-ebdb4294f088.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-182-00ML - Milliliter67457-182e6e9201b-9f8e-45bc-be83-efc5ae87893d12015-10-02
67457-182-10ML - Milliliter67457-18233dc64ce-7de4-459d-a777-22d372c2971012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESMOLOL HYDROCHLORIDEACTIVE INGREDIENTV05260LC8DESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
ESMOLOLACTIVE MOIETYMDY902UXSRESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
SODIUM ACETATE ANHYDROUSINACTIVE INGREDIENTNVG71ZZ7P0ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4
ESMOLOL HYDROCHLORIDEACTIVE INGREDIENTV05260LC8DESMOLOL HYDROCHLORIDE INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
ESMOLOLACTIVE MOIETYMDY902UXSRESMOLOL HYDROCHLORIDE INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PESMOLOL HYDROCHLORIDE INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBESMOLOL HYDROCHLORIDE INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
SODIUM ACETATE ANHYDROUSINACTIVE INGREDIENTNVG71ZZ7P0ESMOLOL HYDROCHLORIDE INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IESMOLOL HYDROCHLORIDE INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RESMOLOL HYDROCHLORIDE INJECTION [GENERAL INJECTABLES AND VACCINES, INC.]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 6 of 15 · 296 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SODIUM ACETATESODIUM ACETATEAmneal Pharmaceuticals Private Limited338105c0-c645-4b84-a125-4e1ead92b8402025-08-11Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: Q40Q9N063P
DENTAL-CHORDACETICUM ACIDUM, AMMONIUM MURIATICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARBOLICUM ACIDUM, CITRUS LIMONUM, CUPRUM METALLICUM, FERRUM METALLICUM, GLYCYRRHIZA GLABRA, LAPPA MAJOR, MEDULLA OSSIS SUIS, MERCURIUS SOLUBILIS, MYRRHA, NATRUM FLUORATUM, PALLADIUM METALLICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEA, STANNUM METALLICUM, STAPHYSAGRIA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, X-RAY, ZINCUM OXYDATUMEnergetix Corporation6c9ba926-7c35-49fd-94d8-988ca0bb772c2025-07-15WarningsExact identifier
unii: Q40Q9N063P
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hydrocortisone and Acetic AcidHYDROCORTISONE AND ACETIC ACIDSun Pharmaceutical Industries, Inc.6383c722-84e2-4719-a13d-19c54e3eefff2025-07-07Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Esmolol HydrochlorideESMOLOL HYDROCHLORIDEHenry Schein, Inc.9c1e3a64-0ef0-4071-ad6f-63ff8789b1982025-06-18Warnings, Adverse reactionsExact identifier
application number: ANDA076474
ndc (package): 0404-9785-10
ndc (product): 0404-9785
rxcui: 1736546
spl id: 20a0bd84-7968-459c-8218-2b2c98beb7d0
spl set id: 9c1e3a64-0ef0-4071-ad6f-63ff8789b198
unii: V05260LC8D
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
hydrocortisone and acetic acidHYDROCORTISONE AND ACETIC ACID OTICSaptalis Pharmaceuticals, LLCd9a3597c-2c9d-46cc-818b-8bb3aa5c4f322025-04-25Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
Bestmade Natural Products BM182 PelletsGRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACIDBestmade Natural Products3242e013-2952-2b56-e063-6294a90a16932025-04-08WarningsExact identifier
unii: QTT17582CB
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
BREVIBLOCESMOLOL HYDROCHLORIDEBaxter Healthcare Company220a07b8-5c68-41a3-8705-fd91f14c50b42025-03-14Warnings, Adverse reactionsExact identifier
unii: V05260LC8D
BREVIBLOCESMOLOL HYDROCHLORIDEBaxter Healthcare Company9c593cdb-cdfe-4492-8862-9b05116aa25e2025-03-14Warnings, Adverse reactionsExact identifier
unii: V05260LC8D
BreviblocESMOLOL HYDROCHLORIDEBaxter Healthcare Company595cc3d5-1306-4828-aefa-5595219ffd622025-03-14Warnings, Adverse reactionsExact identifier
rxcui: 1736546
unii: V05260LC8D
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
Esmolol HydrochlorideESMOLOL HYDROCHLORIDEMylan Institutional LLC94f069f9-dd52-4a69-a103-ebdb4294f0882025-02-27Warnings, Adverse reactionsExact identifier
application number: ANDA076474
ndc (package): 67457-182-10
ndc (package): 67457-182-00
ndc (product): 67457-182
ndc11 (package): 67457018200
rxcui: 1736546
spl id: 677a4e72-7b0a-4f6c-b82e-091d93588566
spl set id: 94f069f9-dd52-4a69-a103-ebdb4294f088
unii: V05260LC8D
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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