esmolol hydrochloride

Generic: esmolol hydrochloride in sodium chloride

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esmolol hydrochloride
Generic Name esmolol hydrochloride in sodium chloride
Labeler eugia us llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

esmolol hydrochloride 20 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-421
Product ID 55150-421_5aebd586-47c6-4e19-88e3-ef0ecb1cc875
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216244
Listing Expiration 2026-12-31
Marketing Start 2022-03-21

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150421
Hyphenated Format 55150-421

Supplemental Identifiers

RxCUI
979432 1736541 1736546
UPC
0355750420012 0355150421015
UNII
V05260LC8D

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name esmolol hydrochloride (source: ndc)
Generic Name esmolol hydrochloride in sodium chloride (source: ndc)
Application Number ANDA216244 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 10 POUCH in 1 CARTON (55150-421-10) / 1 BAG in 1 POUCH (55150-421-01) / 100 mL in 1 BAG
source: ndc

Packages (1)

55150-421-10 10 POUCH in 1 CARTON (55150-421-10) / 1 BAG in 1 POUCH (55150-421-01) / 100 mL in 1 BAG

Ingredients (1)

esmolol hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Esmolol Hydrochloride, esmolol hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5aebd586-47c6-4e19-88e3-ef0ecb1cc875", "openfda": {"upc": ["0355750420012", "0355150421015"], "unii": ["V05260LC8D"], "rxcui": ["979432", "1736541", "1736546"], "spl_set_id": ["ac22475d-2d78-469f-9435-b403ac4ee380"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (55150-421-10)  / 1 BAG in 1 POUCH (55150-421-01)  / 100 mL in 1 BAG", "package_ndc": "55150-421-10", "marketing_start_date": "20220321"}], "brand_name": "esmolol hydrochloride", "product_id": "55150-421_5aebd586-47c6-4e19-88e3-ef0ecb1cc875", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "55150-421", "generic_name": "esmolol hydrochloride in sodium chloride", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "esmolol hydrochloride", "active_ingredients": [{"name": "ESMOLOL HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA216244", "marketing_category": "ANDA", "marketing_start_date": "20220321", "listing_expiration_date": "20261231"}