esmolol hydrochloride

Generic: esmolol hydrochloride

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esmolol hydrochloride
Generic Name esmolol hydrochloride
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

esmolol hydrochloride 100 mg/10mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1444
Product ID 51662-1444_101e0203-54eb-a48a-e063-6294a90af0d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205520
Listing Expiration 2026-12-31
Marketing Start 2019-12-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621444
Hyphenated Format 51662-1444

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 ANDA205520 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/10mL
source: ndc
Packaging
  • 10 mL in 1 VIAL, SINGLE-DOSE (51662-1444-1)
  • 25 POUCH in 1 CASE (51662-1444-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1444-2) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

51662-1444-1 10 mL in 1 VIAL, SINGLE-DOSE (51662-1444-1) 51662-1444-3 25 POUCH in 1 CASE (51662-1444-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1444-2) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

esmolol hydrochloride (100 mg/10mL)

Linked Drug Pages (1)

ESMOLOL HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "101e0203-54eb-a48a-e063-6294a90af0d0", "openfda": {"unii": ["V05260LC8D"], "rxcui": ["1736546"], "spl_set_id": ["9a52d2fd-e551-f8f1-e053-2995a90a6c09"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, SINGLE-DOSE (51662-1444-1)", "package_ndc": "51662-1444-1", "marketing_start_date": "20191222"}, {"sample": false, "description": "25 POUCH in 1 CASE (51662-1444-3)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1444-2)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "51662-1444-3", "marketing_start_date": "20220912"}], "brand_name": "ESMOLOL HYDROCHLORIDE", "product_id": "51662-1444_101e0203-54eb-a48a-e063-6294a90af0d0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "51662-1444", "generic_name": "ESMOLOL HYDROCHLORIDE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ESMOLOL HYDROCHLORIDE", "active_ingredients": [{"name": "ESMOLOL HYDROCHLORIDE", "strength": "100 mg/10mL"}], "application_number": "ANDA205520", "marketing_category": "ANDA", "marketing_start_date": "20191222", "listing_expiration_date": "20261231"}