FDA.reportPublic FDA data

Esmolol Hydrochloride

Product NDC
10019-120
11-digit product format
100190120
Labeler code
10019
Product ID
10019-120_55268328-025c-40f6-9815-edca2c80a97e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esmolol Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA019386
Marketing category
NDA
Marketing start
1986-12-31
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Esmolol Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESMOLOL HYDROCHLORIDE10 mg/mL

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
10019-120-01Esmolol Hydrochloride25 in 1 CARTONINJECTION2515
10019-120-39Esmolol Hydrochloride10 mL in 1 VIALINJECTION1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-120-01ML - Milliliter10019-1203b8126a9-5673-45da-888a-f1abd5ecc91512013-02-13
10019-120-39ML - Milliliter10019-12098f059c6-92da-4bd0-8b8a-bdba162d950512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESMOLOL HYDROCHLORIDEACTIVE INGREDIENTV05260LC8DESMOLOL HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]3
ESMOLOLACTIVE MOIETYMDY902UXSRESMOLOL HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]3
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PESMOLOL HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBESMOLOL HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]3
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BESMOLOL HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XESMOLOL HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IESMOLOL HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]3
WATERINACTIVE INGREDIENT059QF0KO0RESMOLOL HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10019-120ESMOLOL HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]14Current NDC, Legacy NDC, 2 package rows20250213_f0a56c07-8f0f-4499-8d00-f13a966bf988.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736546esmolol HCl 100 MG in 10 ML InjectionPSNf0a56c07-8f0f-4499-8d00-f13a966bf98815
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCDf0a56c07-8f0f-4499-8d00-f13a966bf98815
1736546esmolol HCl 100 MG per 10 ML InjectionSYf0a56c07-8f0f-4499-8d00-f13a966bf98815
1736546esmolol HCl 100 MG in 10 ML InjectionPSN6bdd5315-75ce-1537-e053-2991aa0a65493
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCD6bdd5315-75ce-1537-e053-2991aa0a65493
1736546esmolol HCl 100 MG per 10 ML InjectionSY6bdd5315-75ce-1537-e053-2991aa0a65493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10019-120-011001901200125 VIAL in 1 CARTON (10019-120-01) / 10 mL in 1 VIAL (10019-120-39) 25 vial1986-12-310000-00-00NoNoCurrent
10019-120-391001901203910 mL in 1 VIAL10 mlHistorical