Esmolol

Product NDC
52584-017
11-digit product format
525840017
Labeler code
52584
Product ID
52584-017_53bd9a5c-596a-4692-a48e-676f5f8d8657
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esmolol
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
General Injectables & Vaccines, Inc
Application
NDA019386
Marketing category
NDA
Marketing start
2010-04-01
Marketing end
0000-00-00
Substance
ESMOLOL HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ab3d10ea-fe48-4811-8e72-bb51600b35f9Product name520230103
9cb9173b-3912-466b-8256-366e71d49fceProduct name120190402

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52584-017-412020-01-31C16284748780-19d75b9d0-6ff1-f424-e053-dadaa90a57ceEsmolol HCL 10 mg/mL Injection 10mL Single Dose Vial

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52584-017-41Esmolol1 in 1 BAGINJECTION13
52584-017-41Esmolol10 mL in 1 VIAL, SINGLE-DOSEINJECTION103

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Esmolol HydrochlorideACTIVE INGREDIENTV05260LC8DESMOLOL INJECTION [GENERAL INJECTABLES & VACCINES, INC]2
EsmololACTIVE MOIETYMDY902UXSRESMOLOL INJECTION [GENERAL INJECTABLES & VACCINES, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52584-017ESMOLOL INJECTION [GENERAL INJECTABLES & VACCINES, INC]3Legacy NDC, 2 package rows20170119_35460df2-18d3-4132-85e6-5289bad4c670.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736546esmolol HCl 100 MG in 10 ML InjectionPSN35460df2-18d3-4132-85e6-5289bad4c6703
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD35460df2-18d3-4132-85e6-5289bad4c6703
1736546esmolol HCl 100 MG per 10 ML InjectionSY35460df2-18d3-4132-85e6-5289bad4c6703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52584-017-41525840017411 in 1 BAGHistorical