Atenolol and Chlorthalidone
Atenolol and ChlorthalidoneTablets USPRevised: June 2009Rx only 190808
Approved
Approval ID
84e9de8f-27c3-4177-827a-6992495511ac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 28, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-2683
Application NumberANDA073665
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol and Chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 9, 2010
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
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Atenolol and Chlorthalidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3064
Application NumberANDA073665
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol and Chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 9, 2010
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ATENOLOLActive
Quantity: 100 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
CHLORTHALIDONEActive
Quantity: 25 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT