Active ingredient
Propafenone
53 finished FDA listings contain Propafenone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PROPAFENONE, PROPAFENONE HYDROCHLORIDE
- Dosage forms
- Capsule, Extended Release, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 14
- Strengths listed
- 150 mg/1 · 225 mg/1 · 300 mg/1 · 325 mg/1 · 425 mg/1
- Brand names in FDA listings
- Propafenone Hydrochloride
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8754
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 075938 | STRIDES PHARMA INTL | 2002-10-17 | 8 |
| ANDA 076550 | ANI PHARMS | 2004-04-23 | 15 |
| ANDA 202445 | AUROBINDO PHARMA | 2016-05-11 | 6 |
| ANDA 205268 | GLENMARK PHARMS LTD | 2017-09-08 | 6 |
| ANDA 205956 | RISING | 2018-07-02 | 3 |
| ANDA 210339 | SINOTHERAPEUTICS INC | 2019-01-04 | 3 |
| ANDA 212744 | UPSHER SMITH LABS | 2020-06-25 | 3 |
| ANDA 214184 | ZYDUS LIFESCIENCES | 2021-04-21 | 6 |
| ANDA 213096 | AUROBINDO PHARMA LTD | 2023-02-21 | 3 |
Official labeling on DailyMed
- PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTHSTAR RX LLC] · version 5 · 2026-06-05
- PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED] · version 3 · 2026-05-21
- PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 100 · 2026-04-22
- PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 100 · 2026-04-22
- PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 100 · 2026-04-22
- PROPAFENONE HYDROCHLORIDE TABLET, COATED [A-S MEDICATION SOLUTIONS] · version 6 · 2026-03-30
- PROPAFENONE HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK] · version 101 · 2026-03-02
- PROPAFENONE HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK] · version 101 · 2026-03-02
- PROPAFENONE HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK] · version 101 · 2026-03-02
- PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] · version 8 · 2026-02-02
- PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC] · version 6 · 2025-12-12
- PROPAFENONE HYDROCHLORIDE TABLET, COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 9 · 2025-12-08
Showing the 12 most recent of 27 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.