esmolol hydrochloride

Generic: esmolol hydrochloride

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esmolol hydrochloride
Generic Name esmolol hydrochloride
Labeler henry schein, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

esmolol hydrochloride 10 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9785
Product ID 0404-9785_20a0bd84-7968-459c-8218-2b2c98beb7d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076474
Listing Expiration 2026-12-31
Marketing Start 2025-06-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049785
Hyphenated Format 0404-9785

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 ANDA076474 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BAG (0404-9785-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

0404-9785-10 1 VIAL in 1 BAG (0404-9785-10) / 10 mL in 1 VIAL

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": "20a0bd84-7968-459c-8218-2b2c98beb7d0", "openfda": {"unii": ["V05260LC8D"], "rxcui": ["1736546"], "spl_set_id": ["9c1e3a64-0ef0-4071-ad6f-63ff8789b198"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BAG (0404-9785-10)  / 10 mL in 1 VIAL", "package_ndc": "0404-9785-10", "marketing_start_date": "20250610"}], "brand_name": "Esmolol Hydrochloride", "product_id": "0404-9785_20a0bd84-7968-459c-8218-2b2c98beb7d0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "0404-9785", "generic_name": "esmolol hydrochloride", "labeler_name": "Henry Schein, Inc.", "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": "20250610", "listing_expiration_date": "20261231"}