esmolol hydrochloride

Generic: esmolol hydrochloride

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

Drug Facts

Product Profile

Brand Name esmolol hydrochloride
Generic Name esmolol hydrochloride
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

esmolol hydrochloride 100 mg/10mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-194
Product ID 55150-194_5aebd586-47c6-4e19-88e3-ef0ecb1cc875
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205520
Listing Expiration 2026-12-31
Marketing Start 2015-07-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150194
Hyphenated Format 55150-194

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 (source: ndc)
Application Number ANDA205520 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/10mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-194-10) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-194-10 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-194-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

esmolol hydrochloride (100 mg/10mL)

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": "25 VIAL, SINGLE-DOSE in 1 CARTON (55150-194-10)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-194-10", "marketing_start_date": "20150723"}], "brand_name": "Esmolol Hydrochloride", "product_id": "55150-194_5aebd586-47c6-4e19-88e3-ef0ecb1cc875", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "55150-194", "generic_name": "Esmolol Hydrochloride", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esmolol Hydrochloride", "active_ingredients": [{"name": "ESMOLOL HYDROCHLORIDE", "strength": "100 mg/10mL"}], "application_number": "ANDA205520", "marketing_category": "ANDA", "marketing_start_date": "20150723", "listing_expiration_date": "20261231"}