esmolol hydrochloride

Generic: esmolol hydrochloride

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

esmolol hydrochloride 10 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-182
Product ID 67457-182_677a4e72-7b0a-4f6c-b82e-091d93588566
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076474
Listing Expiration 2026-12-31
Marketing Start 2007-05-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457182
Hyphenated Format 67457-182

Supplemental Identifiers

RxCUI
1736546
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 ANDA076474 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (67457-182-10) / 10 mL in 1 VIAL (67457-182-00)
source: ndc

Packages (1)

67457-182-10 10 VIAL in 1 CARTON (67457-182-10) / 10 mL in 1 VIAL (67457-182-00)

Ingredients (1)

esmolol hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Esmolol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "677a4e72-7b0a-4f6c-b82e-091d93588566", "openfda": {"unii": ["V05260LC8D"], "rxcui": ["1736546"], "spl_set_id": ["94f069f9-dd52-4a69-a103-ebdb4294f088"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (67457-182-10)  / 10 mL in 1 VIAL (67457-182-00)", "package_ndc": "67457-182-10", "marketing_start_date": "20070529"}], "brand_name": "Esmolol Hydrochloride", "product_id": "67457-182_677a4e72-7b0a-4f6c-b82e-091d93588566", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "67457-182", "generic_name": "esmolol hydrochloride", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esmolol Hydrochloride", "active_ingredients": [{"name": "ESMOLOL HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA076474", "marketing_category": "ANDA", "marketing_start_date": "20070529", "listing_expiration_date": "20261231"}