FDA.reportPublic FDA data

NDC 68083-211-01 - 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
68083-211
Requested NDC
68083-211-01
Package NDCs from labels
68083-211-01, 68083-211-25
Manufacturer
Gland Pharma Limited
Effective date
2023-06-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Esmolol Hydrochloride - Gland Pharma LimitedGland Pharma Limited2023-06-23Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-211-01Esmolol Hydrochloride10 mL in 1 VIALINJECTION105
68083-211-25Esmolol Hydrochloride25 in 1 CARTONINJECTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-211ESMOLOL HYDROCHLORIDE INJECTION [GLAND PHARMA LIMITED]5Current NDC, Legacy NDC, 2 package rows20230713_017023a9-00f0-4284-861f-a3634d4fdb17.zip

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 31 of 57 · 1,138 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-88COCCULUS INDICUS, NATRUM MURIATICUM, HELONIAS DIOICA, CALCAREA PHOSPHORICUM, IGNATIA AMARA, MAGNESIA PHOSPHORICUM, CIMICIFUGA RACEMOSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, SEPIA, KALIUM PHOSPHORICUM, ZINCUM METALLICUM, PITUITARY, ADRENAL, OVARIANDNA Labs, Inc.1eefff9c-d86c-44ef-b968-9a8c5a9c54032025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-133CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATEDNA Labs, Inc.a250b7e9-7fd2-4cb0-82f3-baa089d174412025-01-13WarningsExact identifier
unii: 451W47IQ8X
Premixed saline packetsSODIUM CHLORIDE, SODIUM BICARBONATEShenzhen Kerui lntl Trading Co., Ltd0d11e07b-c137-6efc-e063-6394a90a6bba2025-01-09WarningsExact identifier
unii: 451W47IQ8X
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a2b9456-8ca0-8253-e053-2a95a90a8f122025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a2a34f9-ed95-9921-e053-2995a90a0d592025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a2bc45d-e0c8-3af2-e053-2a95a90af0f12025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a67169d-6b15-3406-e053-2995a90a60e42025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a673225-27be-040a-e053-2a95a90a0a982025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a66b61d-82bd-2bbb-e053-2995a90a0b582025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a677063-09d2-8052-e053-2a95a90affae2025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a678fac-289c-0f5c-e053-2995a90a0f432025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a66da0b-ee7b-2b69-e053-2995a90ae9512025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a667d80-d05c-2d18-e053-2995a90a29182025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a66e2a9-a661-e847-e053-2a95a90aa3042025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a67a0bb-6943-2f5f-e053-2a95a90aac6e2025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a6711a9-e0a4-9083-e053-2a95a90ad4a42025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a67bb27-cb44-4a1d-e053-2a95a90a0ee22025-01-09Exact identifier
unii: Q40Q9N063P
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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