MedPath

Atenolol

Atenolol 50mg

Approved
Approval ID

97280ed9-e804-7c8d-e053-2a95a90af142

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 14, 2021

Manufacturers
FDA

RedPharm Drug, Inc.

DUNS: 828374897

Products 1

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 Code67296-1732
Application NumberANDA077443
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2021
FDA Product Classification

INGREDIENTS (8)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ATENOLOLActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Atenolol - FDA Drug Approval Details