Disopyramide Phosphate

Sold as Norpace, Norpace Cr. Every FDA application for this active ingredient: 2 branded and 18 generic.

As of Nov 14, 2026, FDA lists 20 applications for Disopyramide Phosphate (sold as Norpace, Norpace Cr), first approved Sep 1, 1977, with 4 new uses approved and 0 published complete response letters.

First approved: Sep 1, 1977
Applications: 20
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $2.9M

Medicare Spending

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


Disopyramide Phosphate	Part D	$2.3M	-5%	2,506
Norpace Cr	Part D	$537K	-52%	331
Norpace	Part D	$17K	+91%	19

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

DISOPYRAMIDE 100 MG CAPSULE: $0.739 per unitGeneric · -30% in a year
DISOPYRAMIDE 150 MG CAPSULE: $1.52 per unitGeneric · -3% in a year

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive-HCM)Obstructive Hypertrophic Cardiomyopathy · Bristol-Myers Squibb	—	Recruiting	Aug 5, 2022

Applications

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


Sep 1, 1977	NorpaceNDA 17447 · New molecular entity	Pfizer	47	Marketed
Jul 20, 1982	Norpace CrNDA 18655 · New dosage form	Pfizer	31	Discontinued
Feb 22, 1985	Disopyramide PhosphateANDA 70101	Teva	36	Marketed
Feb 22, 1985	Disopyramide PhosphateANDA 70102	Teva	36	Marketed
May 31, 1985	Disopyramide PhosphateANDA 70173	Dr Reddys Labs SA	22	Marketed
Nov 18, 1985	Disopyramide PhosphateANDA 70186	Ivax Sub Teva Pharms	5	Discontinued
Nov 18, 1985	Disopyramide PhosphateANDA 70187	Ivax Sub Teva Pharms	5	Discontinued
Dec 10, 1985	Disopyramide PhosphateANDA 70470	Rising	13	Discontinued
Dec 10, 1985	Disopyramide PhosphateANDA 70471	Rising	13	Discontinued
Dec 17, 1985	Disopyramide PhosphateANDA 70351	Sun Pharm Industries	16	Discontinued
Dec 17, 1985	Disopyramide PhosphateANDA 70352	Sun Pharm Industries	20	Discontinued
Dec 15, 1987	Disopyramide PhosphateANDA 71200	Nesher Pharms	19	Discontinued
—	Disopyramide PhosphateANDA 70138	Mylan	0	Discontinued
—	Disopyramide PhosphateANDA 70139	Mylan	0	Discontinued
—	Disopyramide PhosphateANDA 70240	Watson Labs	0	Discontinued
—	Disopyramide PhosphateANDA 70241	Watson Labs	0	Discontinued
—	Disopyramide PhosphateANDA 70940	Superpharm	0	Discontinued
—	Disopyramide PhosphateANDA 70941	Superpharm	0	Discontinued
—	Disopyramide PhosphateANDA 71190	Interpharm	0	Discontinued
—	Disopyramide PhosphateANDA 71191	Interpharm	0	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