Atenolol
Atenolol Tablets, USP
Approved
Approval ID
71adae77-b8f2-428f-9f56-3c334dffd048
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 17, 2019
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code67544-087
Application NumberANDA073025
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2019
FDA Product Classification
INGREDIENTS (5)
ATENOLOLActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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 Code67544-332
Application NumberANDA073026
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2019
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ATENOLOLActive
Quantity: 100 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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 Code67544-161
Application NumberANDA074052
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2019
FDA Product Classification
INGREDIENTS (5)
ATENOLOLActive
Quantity: 25 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT