MedPath

Atenolol

Atenolol Tablets, USP

Approved
Approval ID

05533121-f28c-4006-bc7d-567988f27e01

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 24, 2010

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

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 Code53808-0346
Application NumberANDA077877
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2010
FDA Product Classification

INGREDIENTS (7)

MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT
ATENOLOLActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
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 Code53808-0345
Application NumberANDA077877
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2010
FDA Product Classification

INGREDIENTS (7)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ATENOLOLActive
Quantity: 100 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
MAGNESIUM CARBONATEInactive
Code: 0E53J927NA
Classification: IACT

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Atenolol - FDA Drug Approval Details