FDA.reportPublic FDA data

Esmolol Hydrochloride

Product NDC
70121-1717
11-digit product format
701211717
Labeler code
70121
Product ID
70121-1717_9fb24e34-22d9-43e6-b611-39e17092e76f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esmolol Hydrochloride in Sodium Chloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA216603
Marketing category
ANDA
Marketing start
2022-12-16
Substance
ESMOLOL HYDROCHLORIDE
Active strength
20 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 HYDROCHLORIDE20 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
70121-1717-3Esmolol Hydrochloride12 in 1 CARTONINJECTION1211
70121-1717-3Esmolol Hydrochloride1 in 1 POUCHINJECTION111
70121-1717-7Esmolol Hydrochloride1 in 1 POUCHINJECTION111
70121-1717-7Esmolol Hydrochloride10 in 1 CARTONINJECTION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1717-1ML - Milliliter70121-17177236d166-4797-480f-9a91-6c47803293b312024-02-14
70121-1717-7ML - Milliliter70121-1717cb89cfdd-9b23-4f96-940e-d6ab9ac4ff6512024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1717ESMOLOL HYDROCHLORIDE (ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE) INJECTION [AMNEAL PHARMACEUTICALS LLC]11Current NDC, Legacy NDC, 4 package rows20241113_4cfdfa50-579b-43e7-bc0a-e831d3099bfd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979432esmolol HCl 2000 MG in 100 ML InjectionPSN4cfdfa50-579b-43e7-bc0a-e831d3099bfd11
1736541esmolol HCl 2500 MG in 250 ML InjectionPSN4cfdfa50-579b-43e7-bc0a-e831d3099bfd11
979432100 ML esmolol hydrochloride 20 MG/ML InjectionSCD4cfdfa50-579b-43e7-bc0a-e831d3099bfd11
1736541250 ML esmolol hydrochloride 10 MG/ML InjectionSCD4cfdfa50-579b-43e7-bc0a-e831d3099bfd11
979432esmolol HCl 2000 MG per 100 ML InjectionSY4cfdfa50-579b-43e7-bc0a-e831d3099bfd11
1736541esmolol HCl 2500 MG per 250 ML InjectionSY4cfdfa50-579b-43e7-bc0a-e831d3099bfd11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1717-37012117170312 POUCH in 1 CARTON (70121-1717-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAG12 pouch2024-01-01NoNoCurrent
70121-1717-77012117170710 POUCH in 1 CARTON (70121-1717-7) / 1 BAG in 1 POUCH / 100 mL in 1 BAG10 pouch2022-12-160000-00-00NoNoCurrent