Betaxolol
Product Images NDC 10135-624

5 FDA label images from Marlex Pharmaceuticals Inc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Betaxolol (NDC 10135-624). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Marlex Pharmaceuticals Inc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

The Following Chemical Structure Of Betaxolol Is A β1-selective (cardioselective) Adrenergic Receptor Blocking Agent Available As 10-mg And 20-mg Tablets For Oral Administration. Betaxolol Is Chemically Described As 2-propanol,1-[4-[2- (cyclopropylmethoxy)ethyl]phenoxy]-3-[(1-methylethyl)amino]-,hydrochloride,(±). (Betaxolol Tablets Usp Film Coated 01)

The Following Chemical Structure Of Betaxolol Is A β1-selective (cardioselective) Adrenergic Receptor Blocking Agent Available As 10-mg And 20-mg  Tablets  For Oral Administration. Betaxolol Is Chemically Described As 2-propanol,1-[4-[2- (cyclopropylmethoxy)ethyl]phenoxy]-3-[(1-methylethyl)amino]-,hydrochloride,(±). (Betaxolol Tablets Usp Film Coated 01)
Chemical structure of Betaxolol hydrochloride, illustrating the molecular arrangement and bonds of the active ingredient.*
FDA Label Image

Betaxolol, Like Other Beta-blockers, Has Been Associated With The Development Of Antinuclear Antibodies (ana) (e.g., Lupus Erythematosus). In Controlled Clinical Studies, Conversion Of Ana From Negative To Positive Occurred In 5.3% Of The Patients Treated With Betaxolol, 6.3% Of The Patients Treated With Atenolol, 4.9% Of The Patients Treated With Propranolol, And 3.2% Of The Patients Treated With Placebo. Betaxolol Adverse Events Reported With A 2% Or Greater Frequency, And Selected Events With Lower Frequency, In U.s. Controlled Studies Are: (Betaxolol Tablets Usp Film Coated 02)

Betaxolol, Like Other Beta-blockers, Has Been Associated With The Development Of Antinuclear Antibodies (ana) (e.g., Lupus Erythematosus). In Controlled Clinical Studies, Conversion Of Ana From Negative To Positive Occurred In 5.3% Of The Patients Treated With Betaxolol, 6.3% Of The Patients Treated With Atenolol, 4.9% Of The Patients Treated With Propranolol, And 3.2% Of The Patients Treated With Placebo. Betaxolol Adverse Events Reported With A 2% Or Greater Frequency, And Selected Events With Lower Frequency, In U.s. Controlled Studies Are: (Betaxolol Tablets Usp Film Coated 02)
A data table presenting adverse reactions by body system for Betaxolol, Propranolol, Atenolol, and Placebo groups, with percentages of patients affected. Adverse reactions are categorized under cardiovascular, central nervous system, psychiatric, autonomic, respiratory, gastrointestinal, musculoskeletal, and skin.*
FDA Label Image

In Europe, The Placebo-controlled Study Lasted For 4 Weeks, While The Comparative Studies Had A 4-52- Week Double-blind Phase. The Following Doses Were Studied: Betaxolol 20 And 40 mg Once Daily And Atenolol 100 mg Once Daily. From European Controlled Hypertension Clinical Trials, The Following Adverse Events Reported By 2% Or More Patients And Selected Events With Lower Frequency Are Presented: (Betaxolol Tablets Usp Film Coated 03)

In Europe, The Placebo-controlled Study Lasted For 4 Weeks, While The Comparative Studies Had A 4-52- Week Double-blind Phase. The Following Doses Were Studied: Betaxolol 20 And 40 mg Once Daily And Atenolol 100 mg Once Daily. From European Controlled Hypertension Clinical Trials, The Following Adverse Events Reported By 2% Or More Patients And Selected Events  With Lower Frequency Are Presented: (Betaxolol Tablets Usp Film Coated 03)
A data table comparing adverse reactions by body system across three groups: Betaxolol (20-40 mg q.d.), Atenolol (100 mg q.d.), and Placebo. It lists percentages of various side effects such as cardiovascular, central nervous system, gastrointestinal, and musculoskeletal reactions for each treatment group.*
FDA Label Image

Principal Display Panelndc 10135-0623-01marlexbetaxololtablets, Usp10 mg100 Film Coated Tabletsrx Only (Betaxolol Tablets Usp Film Coated 04)

Principal Display Panelndc 10135-0623-01marlexbetaxololtablets, Usp10 mg100 Film Coated Tabletsrx Only (Betaxolol Tablets Usp Film Coated 04)
Betaxolol Tablets, USP 10 mg film-coated tablets, labeled by Marlex Pharmaceuticals Inc. The label displays dosage strength, quantity of 100 tablets, and storage instructions. It includes manufacturer and distributor information, lot number, expiration date details, and barcode. The active ingredient Betaxolol Hydrochloride amount per tablet is noted.*
FDA Label Image

Principal Display Panelndc 10135-0624-01marlexbetaxololtablets, Usp20 mg100 Film Coated Tabletsrx Only (Betaxolol Tablets Usp Film Coated 05)

Principal Display Panelndc 10135-0624-01marlexbetaxololtablets, Usp20 mg100 Film Coated Tabletsrx Only (Betaxolol Tablets Usp Film Coated 05)
Betaxolol Tablets USP 20 mg film-coated tablets in a blister pack. Label shows the active ingredient Betaxolol Hydrochloride equivalent to 17.88 mg betaxolol. Manufactured for Marlex Pharmaceuticals Inc, New Castle, DE 19720. Storage instructions indicate 20°C to 25°C. The package contains 100 tablets.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.