MedPath
FDA Approval

CHLORTHALIDONE

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

FDA Approval Summary

Effective Date
November 3, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Chlorthalidone(50 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Inventia Healthcare Limited

JUBILANT CADISTA PHARMACEUTICALS,INC.

677604412

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
59746-761
Application Number
ANDA211320
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 24, 2022
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Code: Q0MQD1073QClass: ACTIBQuantity: 50 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT

CHLORTHALIDONE

Product Details

NDC Product Code
59746-760
Application Number
ANDA211320
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 24, 2022
Code: Q0MQD1073QClass: ACTIBQuantity: 25 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
© Copyright 2025. All Rights Reserved by MedPath