FDA.reportPublic FDA data

Esmolol Hydrochloride in Water

Product NDC
44567-811
11-digit product format
445670811
Labeler code
44567
Product ID
44567-811_0aee9e81-c563-4207-9157-8bf70a163010
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esmolol Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
NDA205703
Marketing category
NDA
Marketing start
2017-12-04
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 in Water
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESMOLOL HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV05260LC8D
Rxcui979432, 1736541

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44567-811-10Esmolol Hydrochloride in Water250 mL in 1 BAGINJECTION25010
44567-811-10Esmolol Hydrochloride in Water10 in 1 CARTONINJECTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-811-10ML - Milliliter44567-81161037f42-a206-474d-8de3-699cca0cba2a12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-811ESMOLOL HYDROCHLORIDE IN WATER (ESMOLOL HYDROCHLORIDE) INJECTION [WG CRITICAL CARE, LLC]10Current NDC, Legacy NDC, 2 package rows20240809_60b10020-f802-4fef-a487-0f11eca246c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979432esmolol HCl 2000 MG in 100 ML InjectionPSN60b10020-f802-4fef-a487-0f11eca246c510
1736541esmolol HCl 2500 MG in 250 ML InjectionPSN60b10020-f802-4fef-a487-0f11eca246c510
979432100 ML esmolol hydrochloride 20 MG/ML InjectionSCD60b10020-f802-4fef-a487-0f11eca246c510
1736541250 ML esmolol hydrochloride 10 MG/ML InjectionSCD60b10020-f802-4fef-a487-0f11eca246c510
979432esmolol HCl 2000 MG per 100 ML InjectionSY60b10020-f802-4fef-a487-0f11eca246c510
1736541esmolol HCl 2500 MG per 250 ML InjectionSY60b10020-f802-4fef-a487-0f11eca246c510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-811-104456708111010 BAG in 1 CARTON (44567-811-10) / 250 mL in 1 BAG10 bag2017-12-040000-00-00NoNoCurrent