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FDA Approval

Chlorthalidone

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
August 20, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Chlorthalidone(25 mg in 1 1)

Products2

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

Chlorthalidone

Product Details

NDC Product Code
0378-0222
Application Number
ANDA086831
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 20, 2019
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
Code: Q0MQD1073QClass: ACTIBQuantity: 25 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT

Chlorthalidone

Product Details

NDC Product Code
0378-0213
Application Number
ANDA086831
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 20, 2019
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
Code: Q0MQD1073QClass: ACTIBQuantity: 50 mg in 1 1
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
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