Chlorthalidone
Approved
Approval ID
950bb805-3ca7-4f54-b4fb-c9e23cb33ae2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2015
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
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 Code54868-2007
Application NumberANDA086831
Product Classification
M
Marketing Category
C73584
G
Generic Name
chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2015
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CHLORTHALIDONEActive
Quantity: 25 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT