Atenolol
Atenolol Tablets USP 25 mg, 50 mg and 100 mg
Approved
Approval ID
c3a23869-1e3f-40f0-9726-833700580113
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code71205-096
Application NumberANDA077443
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2018
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
ATENOLOLActive
Quantity: 25 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB