esmolol hydrochloride

Generic: esmolol hydrochloride

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esmolol hydrochloride
Generic Name esmolol hydrochloride
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

esmolol hydrochloride 20 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-309
Product ID 25021-309_f18c8af9-7dbb-44c2-b1eb-9d0d908f9c9b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207107
Listing Expiration 2026-12-31
Marketing Start 2019-07-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021309
Hyphenated Format 25021-309

Supplemental Identifiers

RxCUI
979432 1736541
UPC
0325021308844 0325021309827
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 ANDA207107 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 10 BAG in 1 CARTON (25021-309-82) / 100 mL in 1 BAG
source: ndc

Packages (1)

25021-309-82 10 BAG in 1 CARTON (25021-309-82) / 100 mL in 1 BAG

Ingredients (1)

esmolol hydrochloride (20 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": "f18c8af9-7dbb-44c2-b1eb-9d0d908f9c9b", "openfda": {"upc": ["0325021308844", "0325021309827"], "unii": ["V05260LC8D"], "rxcui": ["979432", "1736541"], "spl_set_id": ["f12fb0fd-fa05-49fc-b5e3-a2050b816ef2"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 CARTON (25021-309-82)  / 100 mL in 1 BAG", "package_ndc": "25021-309-82", "marketing_start_date": "20190715"}], "brand_name": "esmolol hydrochloride", "product_id": "25021-309_f18c8af9-7dbb-44c2-b1eb-9d0d908f9c9b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "25021-309", "generic_name": "esmolol hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "esmolol hydrochloride", "active_ingredients": [{"name": "ESMOLOL HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA207107", "marketing_category": "ANDA", "marketing_start_date": "20190715", "listing_expiration_date": "20261231"}