FDA.reportPublic FDA data

NDC 63323-652-01 - 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
63323-652
Requested NDC
63323-652-01
Package NDCs from labels
63323-652-01, 63323-652-10
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2024-11-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Esmolol Hydrochloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-11-14HUMAN PRESCRIPTION DRUG LABEL
ESMOLOL HYDROCHLORIDE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2022-12-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-652-01Esmolol Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION106
63323-652-10Esmolol Hydrochloride25 in 1 TRAYINJECTION, SOLUTION256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-652ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 2 package rows20241127_fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-652-01ML - Milliliter63323-652aeaeb99c-9972-48bd-82b2-29e0f2554bbe12025-12-16
63323-652-10ML - Milliliter63323-652f8fba8ad-9d8c-452a-9cc9-2340488e78f912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESMOLOL HYDROCHLORIDEACTIVE INGREDIENTV05260LC8DESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
ESMOLOLACTIVE MOIETYMDY902UXSRESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2

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 16 of 16 · 303 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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