FDA.reportPublic FDA data

NDC 0641-2965-41 - Esmolol

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
0641-2965
Requested NDC
0641-2965-41
Package NDCs from labels
0641-2965-41, 0641-2965-45
Manufacturer
General Injectables & Vaccines, Inc
Effective date
2017-01-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Esmolol - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2017-01-18HUMAN PRESCRIPTION DRUG LABEL
Esmolol Hydrochloride InjectionWest Ward Pharmaceutical Corporation | West Ward Pharmaceutical Corporation, Cherry Hill New Jersey | Lancaster Laboratories2007-11-06HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0641-2965-452019-11-13C16284748780-197449f38-ce57-f6ea-e053-dbdaa90aa703Esmolol Hydrochloride Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-2965-41Esmolol Hydrochloride10 mL in 1 VIALINJECTION102
0641-2965-45Esmolol Hydrochloride25 in 1 BOXINJECTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-2965ESMOLOL HYDROCHLORIDE INJECTION [WEST WARD PHARMACEUTICAL CORPORATION]2Legacy NDC, 2 package rows20120815_a70baf53-e38a-4b23-8905-ee284170236d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-2965-41ML - Milliliter0641-2965fe0e446c-cadc-4f2e-8367-85451bb94d0d12013-02-13
0641-2965-45ML - Milliliter0641-29655d8814a8-0992-452f-a985-6a3fe832378f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Esmolol HydrochlorideACTIVE INGREDIENTV05260LC8DESMOLOL INJECTION [GENERAL INJECTABLES & VACCINES, INC]2
ESMOLOL HYDROCHLORIDEACTIVE INGREDIENTV05260LC8DESMOLOL HYDROCHLORIDE INJECTION [WEST WARD PHARMACEUTICAL CORPORATION]2
EsmololACTIVE MOIETYMDY902UXSRESMOLOL INJECTION [GENERAL INJECTABLES & VACCINES, INC]2
ESMOLOLACTIVE MOIETYMDY902UXSRESMOLOL HYDROCHLORIDE INJECTION [WEST WARD PHARMACEUTICAL CORPORATION]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PESMOLOL HYDROCHLORIDE INJECTION [WEST WARD PHARMACEUTICAL CORPORATION]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBESMOLOL HYDROCHLORIDE INJECTION [WEST WARD PHARMACEUTICAL CORPORATION]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BESMOLOL HYDROCHLORIDE INJECTION [WEST WARD PHARMACEUTICAL CORPORATION]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XESMOLOL HYDROCHLORIDE INJECTION [WEST WARD PHARMACEUTICAL CORPORATION]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IESMOLOL HYDROCHLORIDE INJECTION [WEST WARD PHARMACEUTICAL CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RESMOLOL HYDROCHLORIDE INJECTION [WEST WARD PHARMACEUTICAL CORPORATION]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 31 of 57 · 1,140 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.