FDA.reportPublic FDA data

NDC 44567-450-01 - 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
44567-450
Requested NDC
44567-450-01
Package NDCs from labels
44567-450-01, 44567-450-10
Manufacturer
WG Critical Care, LLC
Effective date
2024-06-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Esmolol Hydrochloride - WG Critical Care, LLCWG Critical Care, LLC2024-06-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44567-450-01Esmolol Hydrochloride250 mL in 1 BAGINJECTION2505
44567-450-10Esmolol Hydrochloride10 in 1 CARTONINJECTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-450ESMOLOL HYDROCHLORIDE (ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE) INJECTION [WG CRITICAL CARE, LLC]4Current NDC, Legacy NDC, 2 package rows20240620_59ba978b-a393-421c-9a67-77e690249d88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-450-01ML - Milliliter44567-45047410b80-326b-47a3-838b-279e3054c82012023-06-06
44567-450-10ML - Milliliter44567-4501ae835d9-158f-4f15-95fa-2639a783e14112023-06-06

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
esmolol hydrochloride in sodium chlorideESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDEMylan Institutional LLC01ad7942-99c3-40ee-9cfb-272fb6c44e2b2026-03-05Warnings, Adverse reactionsExact identifier
rxcui: 979432
rxcui: 1736541
unii: V05260LC8D
Smoke Mix 1023SMOKE MIXProfessional Complementary Health Formulas29c4fb6c-ce90-4f07-94e9-9902b17a3c662026-01-08WarningsExact identifier
unii: 2LQ0UUW8IN
Rubber Gloves/Latex Detox 6029RUBBER GLOVES/LATEX DETOXProfessional Complementary Health Formulas09444130-d35e-4e01-9ba2-005c4b4fe52b2026-01-08WarningsExact identifier
unii: 2LQ0UUW8IN
Esmolol HydrochlorideESMOLOL HYDROCHLORIDEProPharma Distribution3853a26d-782d-f4e7-e063-6294a90a6e472025-12-18Warnings, Adverse reactionsExact identifier
unii: V05260LC8D
BreviblocESMOLOL HYDROCHLORIDEHenry Schein, Inc38a8b23a-fca8-45f4-a09a-9c8b21f522cd2025-10-27Warnings, Adverse reactionsExact identifier
unii: V05260LC8D
Esmolol HydrochlorideESMOLOL HYDROCHLORIDEREMEDYREPACK INC.1f5707f2-a8a7-4a5f-b846-64585b5e3f9f2025-07-29Warnings, Adverse reactionsExact identifier
unii: V05260LC8D
Esmolol HydrochlorideESMOLOL HYDROCHLORIDEHenry Schein, Inc.9c1e3a64-0ef0-4071-ad6f-63ff8789b1982025-06-18Warnings, Adverse reactionsExact identifier
unii: V05260LC8D
BREVIBLOCESMOLOL HYDROCHLORIDEBaxter Healthcare Company220a07b8-5c68-41a3-8705-fd91f14c50b42025-03-14Warnings, Adverse reactionsExact identifier
rxcui: 979432
rxcui: 1736541
unii: V05260LC8D
BREVIBLOCESMOLOL HYDROCHLORIDEBaxter Healthcare Company9c593cdb-cdfe-4492-8862-9b05116aa25e2025-03-14Warnings, Adverse reactionsExact identifier
rxcui: 979432
rxcui: 1736541
unii: V05260LC8D
BreviblocESMOLOL HYDROCHLORIDEBaxter Healthcare Company595cc3d5-1306-4828-aefa-5595219ffd622025-03-14Warnings, Adverse reactionsExact identifier
rxcui: 979432
rxcui: 1736541
unii: V05260LC8D
Esmolol HydrochlorideESMOLOL HYDROCHLORIDEMylan Institutional LLC94f069f9-dd52-4a69-a103-ebdb4294f0882025-02-27Warnings, Adverse reactionsExact identifier
unii: V05260LC8D
ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEHenry Schein, Inc.519cc19c-e2b6-4984-bfad-45276d4cf0e62025-01-27Warnings, Adverse reactionsExact identifier
unii: V05260LC8D
ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9a3e69ab-3ffe-33af-e053-2a95a90a65242025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 1736541
unii: V05260LC8D
Esmolol HydrochlorideESMOLOL HYDROCHLORIDEFresenius Kabi USA, LLCfdc9cea8-0eb4-4930-9e1c-d44bfa9346d22024-11-14Warnings, Adverse reactionsExact identifier
unii: V05260LC8D
Esmolol HydrochlorideESMOLOL HYDROCHLORIDEEugia US LLCac22475d-2d78-469f-9435-b403ac4ee3802024-09-17Warnings, Adverse reactionsExact identifier
rxcui: 979432
rxcui: 1736541
unii: V05260LC8D
Esmolol HydrochlorideESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDEWG Critical Care, LLC59ba978b-a393-421c-9a67-77e690249d882024-06-28Warnings, Adverse reactionsExact identifier
application number: ANDA214172
ndc (package): 44567-451-01
ndc (package): 44567-450-10
ndc (package): 44567-450-01
ndc (package): 44567-451-10
ndc (product): 44567-450
ndc (product): 44567-451
ndc11 (package): 44567045001
rxcui: 979432
rxcui: 1736541
spl id: 2ee062ee-e28c-4bd7-96b3-e02e3e425d8f
spl set id: 59ba978b-a393-421c-9a67-77e690249d88
unii: V05260LC8D
Esmolol Hydrochloride in WaterESMOLOL HYDROCHLORIDEWG Critical Care, LLC60b10020-f802-4fef-a487-0f11eca246c52024-05-31Warnings, Adverse reactionsExact identifier
rxcui: 979432
rxcui: 1736541
unii: V05260LC8D
Esmolol HydrochlorideESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDEAmneal Pharmaceuticals LLC4cfdfa50-579b-43e7-bc0a-e831d3099bfd2024-04-19Warnings, Adverse reactionsExact identifier
rxcui: 979432
rxcui: 1736541
unii: V05260LC8D
ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst789730fa-eaca-4986-e053-2a91aa0a53392024-02-19Warnings, Adverse reactionsExact identifier
unii: V05260LC8D
ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9a52d2fd-e551-f8f1-e053-2995a90a6c092024-01-29Warnings, Adverse reactionsExact identifier
unii: V05260LC8D