esmolol hydrochloride in sodium chloride

Generic: esmolol hydrochloride in sodium chloride

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

Drug Facts

Product Profile

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

esmolol hydrochloride 20 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-658
Product ID 67457-658_f5590283-06f2-43c7-9e1b-2a762f568bbf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206608
Listing Expiration 2026-12-31
Marketing Start 2018-09-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457658
Hyphenated Format 67457-658

Supplemental Identifiers

RxCUI
979432 1736541
UPC
0367457658100
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 in sodium chloride (source: ndc)
Generic Name esmolol hydrochloride in sodium chloride (source: ndc)
Application Number ANDA206608 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 BAG in 1 POUCH (67457-658-10) / 100 mL in 1 BAG
source: ndc

Packages (1)

67457-658-10 1 BAG in 1 POUCH (67457-658-10) / 100 mL in 1 BAG

Ingredients (1)

esmolol hydrochloride (20 mg/mL)

Linked Drug Pages (1)

esmolol hydrochloride in sodium chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f5590283-06f2-43c7-9e1b-2a762f568bbf", "openfda": {"upc": ["0367457658100"], "unii": ["V05260LC8D"], "rxcui": ["979432", "1736541"], "spl_set_id": ["01ad7942-99c3-40ee-9cfb-272fb6c44e2b"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 POUCH (67457-658-10)  / 100 mL in 1 BAG", "package_ndc": "67457-658-10", "marketing_start_date": "20180904"}], "brand_name": "esmolol hydrochloride in sodium chloride", "product_id": "67457-658_f5590283-06f2-43c7-9e1b-2a762f568bbf", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "67457-658", "generic_name": "esmolol hydrochloride in sodium chloride", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "esmolol hydrochloride in sodium chloride", "active_ingredients": [{"name": "ESMOLOL HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA206608", "marketing_category": "ANDA", "marketing_start_date": "20180904", "listing_expiration_date": "20261231"}