MedPath

Atenolol and Chlorthalidone

ATENOLOL AND CHLORTHALIDONE TABLETS USP

Approved
Approval ID

b4cfa459-c1c3-4fe2-ac2d-afeea2b96cca

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 13, 2012

Manufacturers
FDA

Mutual Pharmaceutical Company, Inc.

DUNS: 121735955

Products 2

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

Atenolol and Chlorthalidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53489-532
Application NumberANDA073582
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol and Chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2012
FDA Product Classification

INGREDIENTS (6)

ChlorthalidoneActive
Quantity: 25 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
AtenololActive
Quantity: 100 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
povidonesInactive
Code: FZ989GH94E
Classification: IACT
sodium starch glycolate type a potatoInactive
Code: 5856J3G2A2
Classification: IACT

Atenolol and Chlorthalidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53489-531
Application NumberANDA073582
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol and Chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2012
FDA Product Classification

INGREDIENTS (6)

AtenololActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
ChlorthalidoneActive
Quantity: 25 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
povidonesInactive
Code: FZ989GH94E
Classification: IACT
sodium starch glycolate type a potatoInactive
Code: 5856J3G2A2
Classification: IACT

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Atenolol and Chlorthalidone - FDA Drug Approval Details