Atenolol and Chlorthalidone
Atenolol and Chlorthalidone Tablets, USP
Approved
Approval ID
a85d28c1-e812-4c12-aa67-136bff3610e5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2024
Manufacturers
FDA
Unichem Pharmaceuticals (USA), Inc.
DUNS: 181620514
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 Code29300-400
Application NumberANDA213302
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol and Chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (7)
ATENOLOLActive
Quantity: 50 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CHLORTHALIDONEActive
Quantity: 25 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Atenolol and Chlorthalidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29300-401
Application NumberANDA213302
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atenolol and Chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2024
FDA Product Classification
INGREDIENTS (7)
ATENOLOLActive
Quantity: 100 mg in 1 1
Code: 50VV3VW0TI
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CHLORTHALIDONEActive
Quantity: 25 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT