FDA.reportPublic FDA data

Esmolol Hydrochloride

Product NDC
63323-661
11-digit product format
633230661
Labeler code
63323
Product ID
63323-661_961c04d5-1f12-4095-a4b9-1842574f7f97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESMOLOL HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA076573
Marketing category
ANDA
Marketing start
2004-11-30
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
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
63323-661-04Esmolol Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION106
63323-661-14Esmolol Hydrochloride25 in 1 TRAYINJECTION, SOLUTION256

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESMOLOL HYDROCHLORIDEACTIVE INGREDIENTV05260LC8DESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
ESMOLOLACTIVE MOIETYMDY902UXSRESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-661ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, 2 package rows20241127_fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736546esmolol HCl 100 MG in 10 ML InjectionPSNfdc9cea8-0eb4-4930-9e1c-d44bfa9346d26
173654610 ML esmolol hydrochloride 10 MG/ML InjectionSCDfdc9cea8-0eb4-4930-9e1c-d44bfa9346d26
1736546esmolol HCl 100 MG per 10 ML InjectionSYfdc9cea8-0eb4-4930-9e1c-d44bfa9346d26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63323-661-046332306610410 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
63323-661-146332306611425 VIAL, SINGLE-DOSE in 1 TRAY (63323-661-14) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-661-04) 2025-01-13NoNoCurrent