FDA.reportPublic FDA data

Esmolol Hydrochloride

Product NDC
50090-4699
11-digit product format
500904699
Labeler code
50090
Product ID
50090-4699_f6b1e063-42c8-4a90-a7b6-bae6e29b2046
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esmolol hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA076474
Marketing category
ANDA
Marketing start
2007-05-29
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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
ab3d10ea-fe48-4811-8e72-bb51600b35f9Product name520230103
9cb9173b-3912-466b-8256-366e71d49fceProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4699-02023-01-30C16284748780-1f386c649-e037-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ESMOLOL HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for ESMOLOL HYDROCHLORIDE INJECTION . ESMOLOL HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1986

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4699-0Esmolol Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION101
50090-4699-0Esmolol Hydrochloride10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4699ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20191206_55def2c7-b354-47e6-bd25-6ecd92860795.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736546esmolol HCl 100 MG in 10 ML InjectionPSN55def2c7-b354-47e6-bd25-6ecd928607951
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD55def2c7-b354-47e6-bd25-6ecd928607951
1736546esmolol HCl 100 MG per 10 ML InjectionSY55def2c7-b354-47e6-bd25-6ecd928607951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4699-05009046990010 VIAL in 1 CARTON (50090-4699-0) > 10 mL in 1 VIAL10 vial2019-11-080000-00-00NoNoCurrent