MedPath
FDA Approval

Atenolol

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

FDA Approval Summary

Company
Effective Date
April 18, 2025
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Atenolol(50 mg in 1 1)

Manufacturing Establishments1

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

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

Products1

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
68071-3830
Application Number
ANDA078512
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 18, 2025
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
AtenololActive
Code: 50VV3VW0TIClass: ACTIBQuantity: 50 mg in 1 1

Drug Labeling Information

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


DESCRIPTION SECTION

CLINICAL PHARMACOLOGY SECTION


INDICATIONS & USAGE SECTION

DOSAGE & ADMINISTRATION SECTION


CONTRAINDICATIONS SECTION

WARNINGS SECTION

PRECAUTIONS SECTION


ADVERSE REACTIONS SECTION


OVERDOSAGE SECTION


HOW SUPPLIED SECTION


© Copyright 2025. All Rights Reserved by MedPath