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FDA Approval

Atenolol

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

FDA Approval Summary

Effective Date
May 24, 2010
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.

State of Florida DOH Central Pharmacy

State of Florida DOH Central Pharmacy

829348114

Products2

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
53808-0346
Application Number
ANDA077877
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 24, 2010
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
AtenololActive
Code: 50VV3VW0TIClass: ACTIBQuantity: 50 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT

Atenolol

Product Details

NDC Product Code
53808-0345
Application Number
ANDA077877
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 24, 2010
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
AtenololActive
Code: 50VV3VW0TIClass: ACTIBQuantity: 100 mg in 1 1
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
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