MedPath

Atenolol

Atenolol Tablets.

Approved
Approval ID

f4f06c00-9024-4e04-a882-0da2b24d8ff7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 7, 2023

Manufacturers
FDA

Golden State Medical Supply, Inc.

DUNS: 603184490

Products 3

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

atenolol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60429-027
Application NumberANDA073457
Product Classification
M
Marketing Category
C73584
G
Generic Name
atenolol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 7, 2023
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ATENOLOLActive
Quantity: 25 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB

atenolol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60429-026
Application NumberANDA073457
Product Classification
M
Marketing Category
C73584
G
Generic Name
atenolol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 7, 2023
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ATENOLOLActive
Quantity: 100 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB

atenolol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60429-025
Application NumberANDA073457
Product Classification
M
Marketing Category
C73584
G
Generic Name
atenolol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 7, 2023
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ATENOLOLActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/8/2020

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

LOINC: 34088-5Updated: 1/8/2020

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.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Atenolol - FDA Drug Approval Details