Atenolol
ATENOLOL TABLETS USP
Approved
Approval ID
99721d00-0a3e-4966-8bce-7cfa8a9146b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 19, 2012
Manufacturers
FDA
Mutual Pharmaceutical Company, Inc.
DUNS: 121735955
Products 3
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 Code53489-529
Application NumberANDA073475
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2011
FDA Product Classification
INGREDIENTS (5)
AtenololActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
povidonesInactive
Code: FZ989GH94E
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
Atenolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53489-536
Application NumberANDA074499
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2011
FDA Product Classification
INGREDIENTS (5)
AtenololActive
Quantity: 25 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
povidonesInactive
Code: FZ989GH94E
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
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 Code53489-530
Application NumberANDA073476
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2011
FDA Product Classification
INGREDIENTS (5)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
povidonesInactive
Code: FZ989GH94E
Classification: IACT
AtenololActive
Quantity: 100 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT