FDA.reportPublic FDA data

esmolol hydrochloride

Product NDC
55150-420
11-digit product format
551500420
Labeler code
55150
Product ID
55150-420_5aebd586-47c6-4e19-88e3-ef0ecb1cc875
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esmolol hydrochloride in sodium chloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA216244
Marketing category
ANDA
Marketing start
2022-03-21
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, 1736546

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-420-01esmolol hydrochloride250 mL in 1 BAGINJECTION2506
55150-420-01esmolol hydrochloride1 in 1 POUCHINJECTION16
55150-420-10esmolol hydrochloride10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-420-01ML - Milliliter55150-4206276b70d-8c73-4dfe-be87-4ae9c274bbcc12022-07-06
55150-420-10ML - Milliliter55150-420ab2e0a23-8010-4998-b08b-d9f77dfa6b7512022-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESMOLOL HYDROCHLORIDEACTIVE INGREDIENTV05260LC8DESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
ESMOLOLACTIVE MOIETYMDY902UXSRESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-420ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION ESMOLOL HYDROCHLORIDE (ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE) INJECTION [EUGIA US LLC]6Current NDC, Legacy NDC, 3 package rows20240919_ac22475d-2d78-469f-9435-b403ac4ee380.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736546esmolol HCl 100 MG in 10 ML InjectionPSNac22475d-2d78-469f-9435-b403ac4ee3806
979432esmolol HCl 2000 MG in 100 ML InjectionPSNac22475d-2d78-469f-9435-b403ac4ee3806
1736541esmolol HCl 2500 MG in 250 ML InjectionPSNac22475d-2d78-469f-9435-b403ac4ee3806
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCDac22475d-2d78-469f-9435-b403ac4ee3806
979432100 ML esmolol hydrochloride 20 MG/ML InjectionSCDac22475d-2d78-469f-9435-b403ac4ee3806
1736541250 ML esmolol hydrochloride 10 MG/ML InjectionSCDac22475d-2d78-469f-9435-b403ac4ee3806
1736546esmolol HCl 100 MG per 10 ML InjectionSYac22475d-2d78-469f-9435-b403ac4ee3806
979432esmolol HCl 2000 MG per 100 ML InjectionSYac22475d-2d78-469f-9435-b403ac4ee3806
1736541esmolol HCl 2500 MG per 250 ML InjectionSYac22475d-2d78-469f-9435-b403ac4ee3806

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-420-0155150042001250 mL in 1 BAG250 mlHistorical
55150-420-105515004201010 POUCH in 1 CARTON (55150-420-10) / 1 BAG in 1 POUCH (55150-420-01) / 250 mL in 1 BAG10 pouch2022-03-210000-00-00NoNoCurrent