esmolol hydrochloride

Generic: esmolol hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esmolol hydrochloride
Generic Name esmolol hydrochloride
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

esmolol hydrochloride 10 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-211
Product ID 68083-211_91f3287c-e1f4-48a0-a37e-74da91240a2d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208538
Listing Expiration 2026-12-31
Marketing Start 2019-08-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083211
Hyphenated Format 68083-211

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 ANDA208538 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (68083-211-25) / 10 mL in 1 VIAL (68083-211-01)
source: ndc

Packages (1)

68083-211-25 25 VIAL in 1 CARTON (68083-211-25) / 10 mL in 1 VIAL (68083-211-01)

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": "91f3287c-e1f4-48a0-a37e-74da91240a2d", "openfda": {"unii": ["V05260LC8D"], "rxcui": ["1736546"], "spl_set_id": ["017023a9-00f0-4284-861f-a3634d4fdb17"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (68083-211-25)  / 10 mL in 1 VIAL (68083-211-01)", "package_ndc": "68083-211-25", "marketing_start_date": "20190819"}], "brand_name": "Esmolol Hydrochloride", "product_id": "68083-211_91f3287c-e1f4-48a0-a37e-74da91240a2d", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "68083-211", "generic_name": "Esmolol Hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esmolol Hydrochloride", "active_ingredients": [{"name": "ESMOLOL HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA208538", "marketing_category": "ANDA", "marketing_start_date": "20190819", "listing_expiration_date": "20261231"}