ESMOLOL HYDROCHLORIDE

Product NDC
51662-1322
11-digit product format
516621322
Labeler code
51662
Product ID
51662-1322_11c184fc-7404-be32-e063-6394a90aac35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESMOLOL HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA076474
Marketing category
ANDA
Marketing start
2018-10-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ESMOLOL HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESMOLOL HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV05260LC8D
Rxcui1736546

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1322-1ESMOLOL HYDROCHLORIDE10 mL in 1 VIALINJECTION, SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1322ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]5Current NDC, Legacy NDC, 1 package rows20240220_789730fa-eaca-4986-e053-2a91aa0a5339.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736546esmolol HCl 100 MG in 10 ML InjectionPSN789730fa-eaca-4986-e053-2a91aa0a53395
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD789730fa-eaca-4986-e053-2a91aa0a53395
1736546esmolol HCl 100 MG per 10 ML InjectionSY789730fa-eaca-4986-e053-2a91aa0a53395

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1322-15166213220110 mL in 1 VIAL (51662-1322-1) 10 ml2018-10-190000-00-00NoNoCurrent