Captopril; Hydrochlorothiazide

Sold as Capozide 25/15, Capozide 25/25, Capozide 50/25, Capozide 50/15. Every FDA application for this active ingredient: 1 branded and 5 generic.

As of Nov 15, 2026, FDA lists 6 applications for Captopril; Hydrochlorothiazide (sold as Capozide 25/15, Capozide 25/25, Capozide 50/25 and others), first approved Oct 12, 1984, with 1 new use approved and 0 published complete response letters.

First approved: Oct 12, 1984
Applications: 6
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $18K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Captopril-Hydrochlorothiazide	Part D	$18K	+26%	59

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 12, 1984	Capozide 25/15, Capozide 25/25NDA 18709 · New combination	Apothecon	32	Discontinued
Dec 29, 1997	Captopril And HydrochlorothiazideANDA 74788	Strides Pharma Intl	3	Discontinued
Dec 29, 1997	Captopril And HydrochlorothiazideANDA 74827	Cosette Pharms Nc	7	Discontinued
Dec 29, 1997	Captopril And HydrochlorothiazideANDA 74832	Watson Labs	0	Discontinued
Dec 29, 1997	Captopril And HydrochlorothiazideANDA 74896	Rising	7	Marketed
Jun 18, 1998	Captopril And HydrochlorothiazideANDA 75055	Ivax Sub Teva Pharms	9	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA