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#

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 55 of 55 · 1,087 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation2a96096d-43cc-49b7-af53-b53c17f410012014-07-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationb3b4b176-41f0-4ca8-90d4-3fba5707564a2014-02-21Exact identifier
unii: 451W47IQ8X
TIS-U-SOLSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATEBaxter Healthcare Corporation9da4121f-d62d-4da4-8dfb-0494da16015f2014-02-21Exact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,Baxter Healthcare Corporatione1953d54-818d-46a6-8532-518ebae6d84e2012-06-13Exact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporationf09f80bf-2f8b-4420-865d-aec2d5e5cd4d2012-06-12Exact identifier
unii: 451W47IQ8X
9adad150-da57-4281-bfab-7780c25f26a6a70baf53-e38a-4b23-8905-ee284170236d2007-11-06Warnings, Adverse reactionsExact identifier
spl id: 9adad150-da57-4281-bfab-7780c25f26a6
spl set id: a70baf53-e38a-4b23-8905-ee284170236d

Reported adverse events (FAERS/openFDA)#

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