FDA.reportPublic FDA data

Esmolol Hydrochloride

Product NDC
50090-4512
11-digit product format
500904512
Labeler code
50090
Product ID
50090-4512_da3722d4-d7e2-4521-abc6-3de82a4ec976
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esmolol Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA205520
Marketing category
ANDA
Marketing start
2015-07-23
Marketing end
0000-00-00
Substance
ESMOLOL HYDROCHLORIDE
Active strength
100 mg/10mL
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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ab3d10ea-fe48-4811-8e72-bb51600b35f9Product name520230103
9cb9173b-3912-466b-8256-366e71d49fceProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4512-02023-01-30C16284748780-1f386c64a-2575-0266-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
50090-4512-0Esmolol Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4512-0ML - Milliliter50090-45122e411cb1-3643-4f23-9544-d5852aa9b28612022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4512ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20191005_d407833b-817e-4579-a226-0b02e1b49727.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736546esmolol HCl 100 MG in 10 ML InjectionPSNd407833b-817e-4579-a226-0b02e1b497272
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCDd407833b-817e-4579-a226-0b02e1b497272
1736546esmolol HCl 100 MG per 10 ML InjectionSYd407833b-817e-4579-a226-0b02e1b497272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4512-05009045120010 mL in 1 VIAL, SINGLE-DOSE (50090-4512-0) 10 ml2019-09-060000-00-00NoNoCurrent