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Chlorthalidone

Chlorthalidone Tablets, USP

Approved
Approval ID

ef8023a3-b2be-436e-9085-576781950665

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 5, 2022

Manufacturers
FDA

Zydus Pharmaceuticals USA Inc.

DUNS: 156861945

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Chlorthalidone

PRODUCT DETAILS

NDC Product Code68382-971
Application NumberANDA207813
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 5, 2022
Generic NameChlorthalidone

INGREDIENTS (6)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CHLORTHALIDONEActive
Quantity: 50 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

Chlorthalidone

PRODUCT DETAILS

NDC Product Code68382-970
Application NumberANDA207813
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 5, 2022
Generic NameChlorthalidone

INGREDIENTS (7)

CHLORTHALIDONEActive
Quantity: 25 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

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Chlorthalidone - FDA Drug Approval Details