FDA.reportPublic FDA data

Esmolol Hydrochloride

Product NDC
55150-194
11-digit product format
551500194
Labeler code
55150
Product ID
55150-194_5aebd586-47c6-4e19-88e3-ef0ecb1cc875
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esmolol Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA205520
Marketing category
ANDA
Marketing start
2015-07-23
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
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 HYDROCHLORIDE100 mg/10mL

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
55150-194-10Esmolol Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION106
55150-194-10Esmolol Hydrochloride25 in 1 CARTONINJECTION, SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-194-10ML - Milliliter55150-1947c2c4cca-763b-438c-a731-a36c4dde461612016-03-04

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
55150-194ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION ESMOLOL HYDROCHLORIDE (ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE) INJECTION [EUGIA US LLC]6Current NDC, Legacy NDC, 2 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
1736546esmolol HCl 100 MG in 10 ML InjectionPSN519cc19c-e2b6-4984-bfad-45276d4cf0e65
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD519cc19c-e2b6-4984-bfad-45276d4cf0e65
1736546esmolol HCl 100 MG per 10 ML InjectionSY519cc19c-e2b6-4984-bfad-45276d4cf0e65
1736546esmolol HCl 100 MG in 10 ML InjectionPSN9a52d2fd-e551-f8f1-e053-2995a90a6c094
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD9a52d2fd-e551-f8f1-e053-2995a90a6c094
1736546esmolol HCl 100 MG per 10 ML InjectionSY9a52d2fd-e551-f8f1-e053-2995a90a6c094
1736546esmolol HCl 100 MG in 10 ML InjectionPSN6bb9921c-a0f9-309f-e053-2a91aa0a1e5e3
1736546esmolol HCl 100 MG in 10 ML InjectionPSN3853a26d-782d-f4e7-e063-6294a90a6e473
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD6bb9921c-a0f9-309f-e053-2a91aa0a1e5e3
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD3853a26d-782d-f4e7-e063-6294a90a6e473
1736546esmolol HCl 100 MG per 10 ML InjectionSY6bb9921c-a0f9-309f-e053-2a91aa0a1e5e3
1736546esmolol HCl 100 MG per 10 ML InjectionSY3853a26d-782d-f4e7-e063-6294a90a6e473
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
1736546esmolol HCl 100 MG in 10 ML InjectionPSN1f5707f2-a8a7-4a5f-b846-64585b5e3f9f1
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD1f5707f2-a8a7-4a5f-b846-64585b5e3f9f1
1736546esmolol HCl 100 MG per 10 ML InjectionSY1f5707f2-a8a7-4a5f-b846-64585b5e3f9f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-194-105515001941025 VIAL, SINGLE-DOSE in 1 CARTON (55150-194-10) / 10 mL in 1 VIAL, SINGLE-DOSE2015-07-230000-00-00NoNoCurrent