FDA.reportPublic FDA data

esmolol hydrochloride

Product NDC
25021-308
11-digit product format
250210308
Labeler code
25021
Product ID
25021-308_f18c8af9-7dbb-44c2-b1eb-9d0d908f9c9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esmolol hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA207107
Marketing category
ANDA
Marketing start
2019-07-15
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

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
25021-308-84esmolol hydrochloride10 in 1 CARTONINJECTION, SOLUTION108
25021-308-84esmolol hydrochloride250 mL in 1 BAGINJECTION, SOLUTION2508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-308-84ML - Milliliter25021-308fd997bdb-3563-4bcd-9432-00e55925ba0512020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-308ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]8Current NDC, Legacy NDC, 2 package rows20250313_f12fb0fd-fa05-49fc-b5e3-a2050b816ef2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979432esmolol HCl 2000 MG in 100 ML InjectionPSNf12fb0fd-fa05-49fc-b5e3-a2050b816ef28
1736541esmolol HCl 2500 MG in 250 ML InjectionPSNf12fb0fd-fa05-49fc-b5e3-a2050b816ef28
979432100 ML esmolol hydrochloride 20 MG/ML InjectionSCDf12fb0fd-fa05-49fc-b5e3-a2050b816ef28
1736541250 ML esmolol hydrochloride 10 MG/ML InjectionSCDf12fb0fd-fa05-49fc-b5e3-a2050b816ef28
979432esmolol HCl 2000 MG per 100 ML InjectionSYf12fb0fd-fa05-49fc-b5e3-a2050b816ef28
1736541esmolol HCl 2500 MG per 250 ML InjectionSYf12fb0fd-fa05-49fc-b5e3-a2050b816ef28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-308-842502103088410 BAG in 1 CARTON (25021-308-84) / 250 mL in 1 BAG10 bag2019-07-150000-00-00NoNoCurrent