Atenolol and Chlorthalidone
Revised: December 2012
Approved
Approval ID
18a6026b-a790-44b6-bf03-a17a1a7dac7a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2013
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Atenolol and Chlorthalidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-942
Application NumberANDA073665
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol and Chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2013
FDA Product Classification
INGREDIENTS (6)
ATENOLOLActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
CHLORTHALIDONEActive
Quantity: 25 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT