Is Disopyramide approved by the US FDA?

Drugs@FDA lists 20 application product lines for Disopyramide, including NORPACE (Prescription); NORPACE CR (Prescription); DISOPYRAMIDE PHOSPHATE (Prescription); DISOPYRAMIDE PHOSPHATE (Prescription); DISOPYRAMIDE PHOSPHATE (Prescription).

Is Disopyramide authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 6 products containing Disopyramide, including DISOPYRAMIDE 100 MG CAPSULES; DISOPYRAMIDE NEON 250 MG PROLONGED-RELEASE TABLETS; DISOPYRAMIDE PHOSPHATE 100 MG CAPSULES; DISOPYRAMIDE PHOSPHATE 150 MG CAPSULES; RYTHMODAN 100MG CAPSULES; RYTHMODAN RETARD 250 MG MODIFIED RELEASE TABLETS.

Active substance

Disopyramide

US FDA 20
UK MHRA 6
US price lines 2
NHS prices 2

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
NORPACE	EQ 100MG BASE; EQ 150MG BASE	capsule · oral	PFIZER	Prescription	1 Sep 1977
NORPACE CR	EQ 100MG BASE; EQ 150MG BASE	capsule, extended release · oral	PFIZER	Prescription	20 Jul 1982
DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	capsule · oral	TEVA	Prescription	22 Feb 1985
DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	capsule · oral	TEVA	Prescription	22 Feb 1985
DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE; EQ 150MG BASE	capsule · oral	DR REDDYS LABS SA	Prescription	31 May 1985
DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	capsule · oral	IVAX SUB TEVA PHARMS	Discontinued	18 Nov 1985
DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	capsule · oral	IVAX SUB TEVA PHARMS	Discontinued	18 Nov 1985
DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	capsule · oral	RISING	Discontinued	10 Dec 1985
DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	capsule · oral	RISING	Discontinued	10 Dec 1985
DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	capsule · oral	SUN PHARM INDUSTRIES	Discontinued	17 Dec 1985
DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	capsule · oral	SUN PHARM INDUSTRIES	Discontinued	17 Dec 1985
DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	capsule, extended release · oral	NESHER PHARMS	Discontinued	15 Dec 1987
DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	capsule · oral	MYLAN	Discontinued
DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	capsule · oral	MYLAN	Discontinued
DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	capsule · oral	WATSON LABS	Discontinued
DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	capsule · oral	WATSON LABS	Discontinued
DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	capsule · oral	SUPERPHARM	Discontinued
DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	capsule · oral	SUPERPHARM	Discontinued
DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	capsule · oral	INTERPHARM	Discontinued
DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	capsule · oral	INTERPHARM	Discontinued

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
DISOPYRAMIDE 100 MG CAPSULES	PL 45043/0029	NEON HEALTHCARE LIMITED	POM
DISOPYRAMIDE NEON 250 MG PROLONGED-RELEASE TABLETS	PL 45043/0030	NEON HEALTHCARE LIMITED	POM
DISOPYRAMIDE PHOSPHATE 100 MG CAPSULES	PL 04569/0026	GENERICS (UK) LIMITED	POM
DISOPYRAMIDE PHOSPHATE 150 MG CAPSULES	PL 04569/0027	GENERICS (UK) LIMITED	POM
RYTHMODAN 100MG CAPSULES	PL 45043/0029	NEON HEALTHCARE LIMITED	POM
RYTHMODAN RETARD 250 MG MODIFIED RELEASE TABLETS	PL 45043/0030	NEON HEALTHCARE LIMITED	POM

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DISOPYRAMIDE 100 MG CAPSULE	$0.80053	per EA	23 Sep 2026
US NADAC	DISOPYRAMIDE 150 MG CAPSULE	$1.53179	per EA	23 Sep 2026
NHS Drug Tariff	Disopyramide 100mg capsules	£14.14	84 capsule	1 Oct 2026
NHS Drug Tariff	Disopyramide 250mg modified-release tablets	£32.08	60 tablet	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.

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.