Quick answers
- What is Propafenone hydrochloride used for?
- The FDA-approved label (Propafenone Hydrochloride, Northstar Rx LLC, June 4, 2026) says: “Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Propafenone hydrochloride have a boxed warning?
- Yes. The FDA label for Propafenone Hydrochloride has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Propafenone hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Propafenone hydrochloride been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started March 13, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Propafenone hydrochloride?
- 14 companies list prescription products of Propafenone hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Strides Pharma Science Limited and Aurobindo Pharma Limited.
What Propafenone hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations …
— FDA label: Propafenone Hydrochloride, Northstar Rx LLC, effective June 4, 2026. Read the full label on DailyMed →
The FDA has 27 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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 →
27 of 27 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, extended release · Tablet, coated · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 53 in the FDA NDC Directory |
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 |
|---|---|---|
| propafenone hydrochloride 150 mg tablet, coated | Generic | $0.1173 per tablet |
| propafenone hydrochloride 150 mg tablet, film coated | Generic | $0.1173 per tablet |
| propafenone hydrochloride 225 mg capsule, extended release | Generic | $0.2624 per capsule |
| propafenone hydrochloride 225 mg tablet, coated | Generic | $0.2092 per tablet |
| propafenone hydrochloride 225 mg tablet, film coated | Generic | $0.2092 per tablet |
| propafenone hydrochloride 300 mg tablet, coated | Generic | $0.3699 per tablet |
| propafenone hydrochloride 300 mg tablet, film coated | Generic | $0.3699 per tablet |
| propafenone hydrochloride 325 mg capsule, extended release | Generic | $0.6121 per capsule |
| propafenone hydrochloride 425 mg capsule, extended release | Generic | $0.6045 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.
- Bryant Ranch Prepack11 products
- Strides Pharma Science Limited6 products
- Aurobindo Pharma Limited6 products
- ANI Pharmaceuticals, Inc.3 products
- Vitruvias Therapeutics3 products
- Zydus Lifesciences Limited3 products
- Rising Pharma Holdings, Inc.3 products
- Upsher-Smith Laboratories, LLC3 products
- Glenmark Pharmaceuticals Inc., USA3 products
- NorthStar Rx LLC3 products
- Golden State Medical Supply, Inc.3 products
- Zydus Pharmaceuticals USA Inc.3 products
- American Health Packaging2 products
- A-S Medication Solutions1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (9)
- ANDA075938Strides Pharma Intl · October 17, 2002
- ANDA076550Ani Pharms · April 23, 2004
- ANDA202445Aurobindo Pharma · May 11, 2016
- ANDA205268Glenmark Pharms Ltd · September 8, 2017
- ANDA205956Rising · July 2, 2018
- ANDA210339Sinotherapeutics Inc · January 4, 2019
- ANDA212744Upsher Smith Labs · June 25, 2020
- ANDA214184Zydus Lifesciences · April 21, 2021
- ANDA213096Aurobindo Pharma Ltd · February 21, 2023
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.
-
March 13, 2025 · Class II · Ongoing · D-0316-2025
CGMP Deviations
Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals I — Glenmark Pharmaceuticals Inc., USA
-
March 13, 2025 · Class II · Ongoing · D-0315-2025
CGMP Deviations
Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals — Glenmark Pharmaceuticals Inc., USA
-
March 13, 2025 · Class II · Ongoing · D-0351-2025
CGMP Deviations
Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01. — Glenmark Pharmaceuticals Inc., USA
-
March 13, 2025 · Class II · Ongoing · D-0352-2025
CGMP Deviations
Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. N — Glenmark Pharmaceuticals Inc., USA
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) — Propafenone Hydrochloride, Northstar Rx LLC, effective June 4, 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 →