Last Updated: September 24, 2026

Details for New Drug Application (NDA): 213412

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NDA 213412 describes CHLORTHALIDONE, which is a drug marketed by Abbott, Aiping Pharm Inc, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Ani Pharms, Appco, Ascot, Barr Labs Inc, Chartwell Rx, Cosette Pharms Nc, Dava Pharms Inc, Ingenus Pharms Llc, Inventia, Ipca Labs Ltd, Ivax Pharms, Kv Pharm, Macleods Pharms, Mankind Pharma, Mutual Pharm, Mylan, Pharmobedient, Pioneer Pharms, Purepac Pharm, Sandoz, Sun Pharm Industries, Sunny, Superpharm, Umedica, Unichem, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, and Zydus Pharms, and is included in fifty-nine NDAs. It is available from thirty-six suppliers. Additional details are available on the CHLORTHALIDONE profile page.

The generic ingredient in CHLORTHALIDONE is chlorthalidone. There is one drug master file entry for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the chlorthalidone profile page.

Summary for 213412

Tradename:	CHLORTHALIDONE
Applicant:	Alkem Labs Ltd
Ingredient:	chlorthalidone
Patents:	0

Pharmacology for NDA: 213412

Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for 213412

Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 213412

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORTHALIDONE	chlorthalidone	TABLET;ORAL	213412	ANDA	A-S Medication Solutions	50090-5183	50090-5183-1	30 TABLET in 1 BOTTLE (50090-5183-1)
CHLORTHALIDONE	chlorthalidone	TABLET;ORAL	213412	ANDA	A-S Medication Solutions	50090-6126	50090-6126-1	30 TABLET in 1 BOTTLE (50090-6126-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Feb 11, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Feb 11, 2020	TE:	AB	RLD:	No

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