esmolol hydrochloride

Generic: esmolol hydrochloride

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esmolol hydrochloride
Generic Name esmolol hydrochloride
Labeler propharma distribution
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

esmolol hydrochloride 100 mg/10mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-194
Product ID 84549-194_463cc756-d1d0-9ffe-e063-6394a90ab342
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 84549194
Hyphenated Format 84549-194

Supplemental Identifiers

RxCUI
1736546
UNII
V05260LC8D

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
  • 10 mL in 1 VIAL, SINGLE-DOSE (84549-194-10)
source: ndc

Packages (1)

84549-194-10 10 mL in 1 VIAL, SINGLE-DOSE (84549-194-10)

Ingredients (1)

esmolol hydrochloride (100 mg/10mL)

Linked Drug Pages (1)

Esmolol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "463cc756-d1d0-9ffe-e063-6394a90ab342", "openfda": {"unii": ["V05260LC8D"], "rxcui": ["1736546"], "spl_set_id": ["3853a26d-782d-f4e7-e063-6294a90a6e47"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, SINGLE-DOSE (84549-194-10)", "package_ndc": "84549-194-10", "marketing_start_date": "20250827"}], "brand_name": "Esmolol Hydrochloride", "product_id": "84549-194_463cc756-d1d0-9ffe-e063-6394a90ab342", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "84549-194", "generic_name": "Esmolol Hydrochloride", "labeler_name": "ProPharma Distribution", "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"}