CHLORTHALIDONE
Chlorthalidone Tablets, USP
Approved
Approval ID
1b98d1a1-9d3d-41d2-a5e9-744b851d30d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 6, 2022
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
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 Code46708-677
Application NumberANDA216262
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORTHALIDONE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2022
FDA Product Classification
INGREDIENTS (8)
CHLORTHALIDONEActive
Quantity: 50 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
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 Code46708-676
Application NumberANDA216262
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORTHALIDONE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2022
FDA Product Classification
INGREDIENTS (8)
CHLORTHALIDONEActive
Quantity: 25 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT