MedPath

Benzonatate

Generic Name
Benzonatate
Drug Type
Small Molecule
Chemical Formula
C30H53NO11
CAS Number
104-31-4
Unique Ingredient Identifier
5P4DHS6ENR

Overview

Benzonatate is an oral antitussive drug used in the relief and suppression of cough in patients older than ten years of age. Currently, benzonatate is the only non-narcotic antitussive available as a prescription drug. It works to reduce the activity of cough reflex by desensitizing the tissues of the lungs and pleura involved in the cough reflex. Benzonatate was approved by the FDA in 1958 under the market name Tessalon Perles. Because its chemical structure resembles that of the anesthetic agents in the para-amino-benzoic acid class (such as procaine and tetracaine), benzonatate exhibits anesthetic or numbing action. Although it not prone to drug misuse or abuse, benzonatate is associated with a risk for severe toxicity and overdose, especially in children.

Indication

用于急性支气管炎、支气管哮喘、肺炎、肺癌索引起的刺激性干咳、阵咳等,也可用于支气管镜、喉镜或支气管造影前预防咳嗽。

Associated Conditions

  • Cough

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Ascend Laboratories LLC
67877-574
ORAL
150 mg in 1 1
3/22/2017
Bryant Ranch Prepack
72162-1561
ORAL
100 mg in 1 1
8/29/2023
Amneal Pharmaceuticals LLC
65162-537
ORAL
200 mg in 1 1
12/18/2023
A-S Medication Solutions
50090-6294
ORAL
200 mg in 1 1
12/21/2018
Proficient Rx LP
63187-016
ORAL
100 mg in 1 1
11/1/2019
Preferred Pharmaceuticals Inc.
68788-8329
ORAL
200 mg in 1 1
3/1/2024
Northwind Pharmaceuticals, LLC
51655-769
ORAL
100 mg in 1 1
10/30/2015
American Health Packaging
68084-214
ORAL
100 mg in 1 1
8/31/2022
XLCare Pharmaceuticals, Inc.
72865-117
ORAL
100 mg in 1 1
1/21/2022
RedPharm Drug Inc.
67296-0567
ORAL
100 mg in 1 1
7/6/2011

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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