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Atenolol

Atenolol Tablets, USP

Approved
Approval ID

bfe631e8-ab7d-40d0-b42e-ed1102955c44

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 2, 2014

Manufacturers
FDA

ReadyMeds

DUNS: 072115132

Products 2

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 Code64205-078
Application NumberANDA074052
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2014
FDA Product Classification

INGREDIENTS (5)

ATENOLOLActive
Quantity: 25 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

Atenolol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code64205-506
Application NumberANDA073025
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2014
FDA Product Classification

INGREDIENTS (5)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ATENOLOLActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

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Atenolol - FDA Drug Approval Details