FDA.reportPublic FDA data

ESMOLOL HYDROCHLORIDE

Product NDC
0404-9858
11-digit product format
004049858
Labeler code
0404
Product ID
0404-9858_8130e9c3-a1f5-4853-9a39-aa54181f1966
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESMOLOL HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA205520
Marketing category
ANDA
Marketing start
2022-01-10
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
Rxcui1736546

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
0404-9858-10ESMOLOL HYDROCHLORIDE1 in 1 BAGINJECTION, SOLUTION15
0404-9858-10ESMOLOL HYDROCHLORIDE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9858ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.]5Current NDC, Legacy NDC, 2 package rows20250129_519cc19c-e2b6-4984-bfad-45276d4cf0e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9858-10004049858101 VIAL, SINGLE-DOSE in 1 BAG (0404-9858-10) / 10 mL in 1 VIAL, SINGLE-DOSE2022-01-100000-00-00NoNoCurrent