Atenolol
Atenolol Tablets, USP
Approved
Approval ID
36fdf50e-6714-3353-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 6, 2016
Manufacturers
FDA
Apotheca Inc.
DUNS: 051457844
Products 1
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 Code12634-605
Application NumberANDA076900
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2016
FDA Product Classification
INGREDIENTS (7)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ATENOLOLActive
Quantity: 100 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT