Atenolol
Atenolol Tablets, USPRx only
Approved
Approval ID
35d99c43-7305-4a4a-886e-a9bf3ee88fa8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2024
Manufacturers
FDA
Unichem Pharmaceuticals (USA), Inc.
DUNS: 181620514
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 Code29300-412
Application NumberANDA213136
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (6)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ATENOLOLActive
Quantity: 100 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
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 Code29300-410
Application NumberANDA213136
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (6)
ATENOLOLActive
Quantity: 25 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Atenolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29300-411
Application NumberANDA213136
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (6)
ATENOLOLActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT