Quick answers
- What is Disopyramide phosphate used for?
- The FDA-approved label (Norpace, Pfizer Laboratories Div Pfizer Inc, August 24, 2026) says: “Norpace and Norpace CR are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Disopyramide phosphate have a boxed warning?
- Yes. The FDA label for Norpace has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Disopyramide phosphate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Disopyramide phosphate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started December 2, 2015 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Disopyramide phosphate?
- 4 companies list prescription products of Disopyramide phosphate in the FDA NDC Directory, including Dr. Reddy's Labratories Inc., Mylan Pharmaceuticals Inc. and Pfizer Laboratories Div Pfizer Inc.
What Disopyramide phosphate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Norpace and Norpace CR are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. …
— FDA label: Norpace, Pfizer Laboratories Div Pfizer Inc, effective August 24, 2026. Read the full label on DailyMed →
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
3 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Capsule, gelatin coated |
|---|---|
| Route | Oral |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Norpace |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| disopyramide phosphate 100 mg capsule | Generic | $0.7389 per capsule |
| disopyramide phosphate 100 mg capsule, gelatin coated | Generic | $0.7389 per capsule |
| disopyramide phosphate 150 mg capsule | Generic | $1.52 per capsule |
| disopyramide phosphate 150 mg capsule, gelatin coated | Generic | $1.52 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Dr. Reddy's Labratories Inc.2 products
- Mylan Pharmaceuticals Inc.2 products
- Pfizer Laboratories Div Pfizer Inc2 products
- Teva Pharmaceuticals USA, Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017447 NORPACE | Pfizer | September 1, 1977 | 47, latest May 17, 2000 2000: Labeling · 1998: Labeling · 1998: Manufacturing (CMC) |
Generic approvals (3)
- ANDA070101Teva · February 22, 1985
- ANDA070102Teva · February 22, 1985
- ANDA070173DR Reddys Labs SA · May 31, 1985
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
December 2, 2015 · Class III · Terminated · D-0520-2016
Failed Dissolution Specification
Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Divisio — Pfizer Inc.
-
May 31, 2013 · Class III · Terminated · D-607-2013
Failed Dissolution Specification
Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Divisio — Pfizer Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Norpace, Pfizer Laboratories Div Pfizer Inc, effective August 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →