CHLORTHALIDONE
Chlorthalidone Tablets, USP
Approved
Approval ID
ca0df4ae-c424-44d2-8611-1637f1a101a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2022
Manufacturers
FDA
JUBILANT CADISTA PHARMACEUTICALS,INC.
DUNS: 022490515
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chlorthalidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-761
Application NumberANDA211320
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2022
FDA Product Classification
INGREDIENTS (8)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CHLORTHALIDONEActive
Quantity: 50 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Chlorthalidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-760
Application NumberANDA211320
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2022
FDA Product Classification
INGREDIENTS (7)
CHLORTHALIDONEActive
Quantity: 25 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT