HEMICLOR
These highlights do not include all the information needed to use HEMICLORsafely and effectively. See full prescribing information for HEMICLOR. HEMICLOR (chlorthalidone) tablets, for oral useInitial U.S. Approval: 1960
Approved
Approval ID
3f0f3ee0-f5a6-4bda-8160-a77744e9fa46
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 27, 2025
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
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 Code50742-285
Application NumberNDA218647
Product Classification
M
Marketing Category
C73594
G
Generic Name
chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2025
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CHLORTHALIDONEActive
Quantity: 12.5 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT