esmolol hydrochloride

Generic: esmolol hydrochloride in sodium chloride

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

esmolol hydrochloride 20 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-1717
Product ID 70121-1717_9fb24e34-22d9-43e6-b611-39e17092e76f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216603
Listing Expiration 2026-12-31
Marketing Start 2022-12-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 701211717
Hyphenated Format 70121-1717

Supplemental Identifiers

RxCUI
979432 1736541
UPC
0370121171638 0370121171676 0370121171775 0370121171614
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 in sodium chloride (source: ndc)
Application Number ANDA216603 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 12 POUCH in 1 CARTON (70121-1717-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
  • 10 POUCH in 1 CARTON (70121-1717-7) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
source: ndc

Packages (2)

70121-1717-3 12 POUCH in 1 CARTON (70121-1717-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAG 70121-1717-7 10 POUCH in 1 CARTON (70121-1717-7) / 1 BAG in 1 POUCH / 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": "9fb24e34-22d9-43e6-b611-39e17092e76f", "openfda": {"upc": ["0370121171638", "0370121171676", "0370121171775", "0370121171614"], "unii": ["V05260LC8D"], "rxcui": ["979432", "1736541"], "spl_set_id": ["4cfdfa50-579b-43e7-bc0a-e831d3099bfd"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CARTON (70121-1717-3)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG", "package_ndc": "70121-1717-3", "marketing_start_date": "20240101"}, {"sample": false, "description": "10 POUCH in 1 CARTON (70121-1717-7)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG", "package_ndc": "70121-1717-7", "marketing_start_date": "20221216"}], "brand_name": "Esmolol Hydrochloride", "product_id": "70121-1717_9fb24e34-22d9-43e6-b611-39e17092e76f", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "70121-1717", "generic_name": "Esmolol Hydrochloride in Sodium Chloride", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esmolol Hydrochloride", "active_ingredients": [{"name": "ESMOLOL HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA216603", "marketing_category": "ANDA", "marketing_start_date": "20221216", "listing_expiration_date": "20261231"}