Is Captopril registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 9 valid registrations of Captopril, including ACETAB 25 MG TABLETS (25 mg, Tablet, SAR 20.25); ACETAB 50 MG TABLETS (50 mg, Tablet, SAR 34.20); Acetab (1 mg/ml, Oral solution, SAR 133.40); CAPOCARD 25MG TAB (25 mg, Tablet, SAR 15.15); CAPOCARD 50MG TAB (50 mg, Tablet, SAR 25.40).

Is Captopril approved by the US FDA?

Drugs@FDA lists 27 application product lines for Captopril, including CAPTOPRIL (Prescription); CAPTOPRIL (Prescription); CAPTOPRIL (Prescription); CAPTOPRIL (Prescription); CAPTOPRIL (Prescription).

Are there safety signals or safety updates for Captopril?

US FDA: 1 entry (latest 2017-08-01).

Active substance

Captopril

SFDA 16
US FDA 27
Health Canada 9
US price lines 4
NHS prices 5
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ACETAB 25 MG TABLETS	25 mg	Tablet · Oral use	30 Blister	SAR 20.25	Generic · Prescription	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
ACETAB 50 MG TABLETS	50 mg	Tablet · Oral use	30 Blister	SAR 34.20	Generic · Prescription	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
Acetab	1 mg/ml	Oral solution · Oral use	1 Bottle	SAR 133.40	Generic · Prescription	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
CAPOCARD 25MG TAB	25 mg	Tablet · Oral use	20 Blister	SAR 15.15	Generic · Prescription	DAR ALDAWA	Valid
CAPOCARD 50MG TAB	50 mg	Tablet · Oral use	20 Blister	SAR 25.40	Generic · Prescription	DAR ALDAWA	Valid
CAPRIL 25MG TAB	25 mg	Tablet · Oral use	20 Blister	SAR 18.65	Generic · Prescription	SPIMACO ADDWAEIH	Valid
CAPRIL 50MG TAB	50 mg	Tablet · Oral use	20 Blister	SAR 31.55	Generic · Prescription	SPIMACO ADDWAEIH	Valid
NOYADA 25MG/5ML ORAL SOLUTION	5 mg	Oral solution · Oral use	1 Bottle	SAR 165.00	NCE · Prescription	MACARTHYS LABORATORIES Ltd T/A MARTINDALE PHARMACEUTICALS	Valid
NOYADA 5MG/5ML ORAL SOLUTION	1 mg	Oral solution · Oral use	1 Bottle	SAR 140.40	NCE · Prescription	MACARTHYS LABORATORIES Ltd T/A MARTINDALE PHARMACEUTICALS	Valid
CAPOTEN 25MG TAB	25 mg	Tablet · Oral use	20 Blister	SAR 18.65	NCE · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
CAPOTEN 50MG TAB	50 mg	Tablet · Oral use	20 Blister	SAR 31.55	NCE · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
CAPTOPHAR 25MG TABLETS	25 mg	Tablet · Oral use	30 Blister	SAR 17.80	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Withdrawn by MAH · Not Marketed
CAPTOPHAR 50MG TABLETS	50 mg	Tablet · Oral use	28 Blister	SAR 28.10	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Withdrawn by MAH · Not Marketed
NOVO-CAPTORIL 12.5MG TAB	12.5 mg	Tablet · Oral use	20 Blister	SAR 11.55	Generic · Prescription	NOVOPHARM	Withdrawn by MAH · Not Marketed
NOVO-CAPTORIL 25MG TAB	25 mg	Tablet · Oral use	20 Blister	SAR 18.25	Generic · Prescription	NOVOPHARM	Withdrawn by MAH · Not Marketed
NOVO-CAPTORIL 50MG TAB	50 mg	Tablet · Oral use	20 Blister	SAR 29.10	Generic · Prescription	NOVOPHARM	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

CARDIOMYOPATHY; CHRONIC KIDNEY DISEASE; CONGESTIVE HEART FAILURE; CORONARY ARTERY DISEASE; HYPERTENSION; NON-ST WAVE ELEVATED MYOCARDIAL INFARCTION (NSTEMI); SICKLE CELL DISEASE - ALBUMINURIA MANAGEMENT; ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI)

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	PRINSTON INC	Prescription	13 Feb 1996
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	HIKMA INTL PHARMS	Prescription	13 Feb 1996
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	WOCKHARDT BIO AG	Prescription	28 Mar 1997
CAPTOPRIL	50MG; 25MG; 100MG; 12.5MG	tablet · oral	ANDAS 5 HOLDING	Prescription	30 May 1997
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	COREPHARMA	Prescription	28 Oct 1998
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	AJANTA PHARMA LTD	Prescription	13 Dec 2019
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	AIPING PHARM INC	Prescription	27 Jan 2023
CAPOTEN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	AARXION ANDA HLDING	Discontinued	6 Apr 1981
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	APOTHECON	Discontinued	31 Mar 1995
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	CHARTWELL RX	Discontinued	9 Nov 1995
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	TEVA	Discontinued	13 Feb 1996
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	TP ANDA HOLDINGS	Discontinued	13 Feb 1996
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	DAVA PHARMS INC	Discontinued	13 Feb 1996
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	COSETTE PHARMS NC	Discontinued	13 Feb 1996
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	AUROBINDO PHARMA USA	Discontinued	13 Feb 1996
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	WATSON LABS	Discontinued	13 Feb 1996
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	COSETTE PHARMS NC	Discontinued	13 Feb 1996
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	SANDOZ	Discontinued	13 Feb 1996
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	COSETTE PHARMS NC	Discontinued	13 Feb 1996
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	STRIDES PHARMA INTL	Discontinued	13 Feb 1996
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	CHARTWELL RX	Discontinued	13 Feb 1996
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	WATSON LABS	Discontinued	23 Apr 1996
CAPTOPRIL	12.5MG; 25MG; 50MG; 100MG	tablet · oral	WATSON LABS	Discontinued	23 May 1996
CAPTOPRIL	50MG; 25MG; 100MG; 12.5MG	tablet · oral	G AND W LABS INC	Discontinued	30 Aug 1996
CAPTOPRIL	50MG; 25MG; 100MG; 12.5MG	tablet · oral	EGIS PHARMS	Discontinued	29 May 1997

2 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-CAPTO TAB 100MG	00893625	100 MG	TABLET · ORAL	APOTEX INC
APO-CAPTO TAB 12.5MG	00893595	12.5 MG	TABLET · ORAL	APOTEX INC
APO-CAPTO TAB 50MG	00893617	50 MG	TABLET · ORAL	APOTEX INC
NOYADA	02543907	5 MG / 5 ML	SOLUTION · ORAL	ETHYPHARM INC
NOYADA	02543915	25 MG / 5 ML	SOLUTION · ORAL	ETHYPHARM INC
TEVA-CAPTOPRIL	01942964	12.5 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-CAPTOPRIL	01942972	25 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-CAPTOPRIL	01942980	50 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-CAPTOPRIL	01942999	100 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CAPTOPRIL 100 MG TABLET	$0.32292	per EA	2 Sep 2026
US NADAC	CAPTOPRIL 12.5 MG TABLET	$0.22839	per EA	23 Sep 2026
US NADAC	CAPTOPRIL 25 MG TABLET	$0.17282	per EA	23 Sep 2026
US NADAC	CAPTOPRIL 50 MG TABLET	$0.36903	per EA	23 Sep 2026
NHS Drug Tariff	Captopril 12.5mg tablets	£28.17	56 tablet	1 Oct 2026
NHS Drug Tariff	Captopril 25mg tablets	£57.63	56 tablet	1 Oct 2026
NHS Drug Tariff	Captopril 25mg/5ml oral solution sugar free	£101.00	100 ml	1 Oct 2026
NHS Drug Tariff	Captopril 50mg tablets	£55.13	56 tablet	1 Oct 2026
NHS Drug Tariff	Captopril 5mg/5ml oral solution sugar free	£93.30	100 ml	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 1 Aug 2017 CAPOTEN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions

All safety entries for captopril →

Combinations containing Captopril

Captopril + hydrochlorothiazide

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.