FDA.reportPublic FDA data

Esmolol Hydrochloride

Product NDC
44567-450
11-digit product format
445670450
Labeler code
44567
Product ID
44567-450_2ee062ee-e28c-4bd7-96b3-e02e3e425d8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esmolol Hydrochloride in Sodium Chloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA214172
Marketing category
ANDA
Marketing start
2022-12-07
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
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
44567-450-01Esmolol Hydrochloride250 mL in 1 BAGINJECTION2505
44567-450-10Esmolol Hydrochloride10 in 1 CARTONINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-450-01ML - Milliliter44567-45047410b80-326b-47a3-838b-279e3054c82012023-06-06
44567-450-10ML - Milliliter44567-4501ae835d9-158f-4f15-95fa-2639a783e14112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-450ESMOLOL HYDROCHLORIDE (ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE) INJECTION [WG CRITICAL CARE, LLC]4Current NDC, Legacy NDC, 2 package rows20240620_59ba978b-a393-421c-9a67-77e690249d88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979432esmolol HCl 2000 MG in 100 ML InjectionPSN59ba978b-a393-421c-9a67-77e690249d885
1736541esmolol HCl 2500 MG in 250 ML InjectionPSN59ba978b-a393-421c-9a67-77e690249d885
979432100 ML esmolol hydrochloride 20 MG/ML InjectionSCD59ba978b-a393-421c-9a67-77e690249d885
1736541250 ML esmolol hydrochloride 10 MG/ML InjectionSCD59ba978b-a393-421c-9a67-77e690249d885
979432esmolol HCl 2000 MG per 100 ML InjectionSY59ba978b-a393-421c-9a67-77e690249d885
1736541esmolol HCl 2500 MG per 250 ML InjectionSY59ba978b-a393-421c-9a67-77e690249d885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-450-0144567045001250 mL in 1 BAG250 mlHistorical
44567-450-104456704501010 BAG in 1 CARTON (44567-450-10) / 250 mL in 1 BAG (44567-450-01) 10 bag2022-12-070000-00-00NoNoCurrent