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FDA Approval

Atenolol

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
August 7, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Atenolol(25 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Golden State Medical Supply, Inc.

Golden State Medical Supply, Inc.

603184490

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Atenolol

Product Details

NDC Product Code
60429-027
Application Number
ANDA073457
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 7, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
AtenololActive
Code: 50VV3VW0TIClass: ACTIBQuantity: 25 mg in 1 1

Atenolol

Product Details

NDC Product Code
60429-026
Application Number
ANDA073457
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 7, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
AtenololActive
Code: 50VV3VW0TIClass: ACTIBQuantity: 100 mg in 1 1

Atenolol

Product Details

NDC Product Code
60429-025
Application Number
ANDA073457
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 7, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
AtenololActive
Code: 50VV3VW0TIClass: ACTIBQuantity: 50 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 100 mg

NDC 60429-026-10

Atenolol


** Tablets, USP**


** 100 mg**

Rx only 1000 Tablets

Each tablet contains:

Atenolol, USP 100 mg

Dispense in a tight, light-resistant

container as defined in the USP

using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication


** out of the reach of children.**

Store at 20° to 25°C (68° to 77°F).


** [See USP Controlled Room** **** ** Temperature.]**

Usual Dosage: One tablet daily or as

directed by physician. See accompanying

prescribing information.

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Made in Australia

Mylan.com

3389/0

RALP0757A

Marketed by:

GSMS, Inc.

Camarillo, CA USA 93012

Atenolol Tablets - 60429-026-10LB - Rev 0723.jpg


OVERDOSAGE SECTION

OVERDOSAGE

Overdosage with atenolol tablets has been reported with patients surviving acute doses as high as 5 g. One death was reported in a man who may have taken as much as 10 g acutely.

The predominant symptoms reported following atenolol tablets overdose are lethargy, disorder of respiratory drive, wheezing, sinus pause and bradycardia. Additionally, common effects associated with overdosage of any beta-adrenergic blocking agent and which might also be expected in atenolol tablets overdose are congestive heart failure, hypotension, bronchospasm and/or hypoglycemia.

Treatment of overdose should be directed to the removal of any unabsorbed drug by induced emesis, gastric lavage, or administration of activated charcoal. Atenolol tablets can be removed from the general circulation by hemodialysis. Other treatment modalities should be employed at the physician’s discretion and may include:

Bradycardia

Atropine intravenously. If there is no response to vagal blockade, give isoproterenol cautiously. In refractory cases, a transvenous cardiac pacemaker may be indicated.

Heart Block (Second or Third Degree)

Isoproterenol or transvenous cardiac pacemaker.

Cardiac Failure

Digitalize the patient and administer a diuretic. Glucagon has been reported to be useful.

Hypotension

Vasopressors such as dopamine or norepinephrine (levarterenol). Monitor blood pressure continuously.

Bronchospasm

A beta 2 stimulant such as isoproterenol or terbutaline and/or aminophylline.

Hypoglycemia

Intravenous glucose.

Based on the severity of symptoms, management may require intensive support care and facilities for applying cardiac and respiratory support.


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