Atenolol
Approved
Approval ID
8dd93a47-d14c-49be-9c22-97c0cdbec75a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
Mylan Institutional Inc.
DUNS: 039615992
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 Code51079-684
Application NumberANDA073457
Product Classification
M
Marketing Category
C73584
G
Generic Name
atenolol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ATENOLOLActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
atenolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51079-759
Application NumberANDA073457
Product Classification
M
Marketing Category
C73584
G
Generic Name
atenolol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ATENOLOLActive
Quantity: 25 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
atenolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51079-685
Application NumberANDA073457
Product Classification
M
Marketing Category
C73584
G
Generic Name
atenolol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ATENOLOLActive
Quantity: 100 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB