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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.

ApplicationSponsorOriginal approvalListings
ANDA 075938STRIDES PHARMA INTL2002-10-178
ANDA 076550ANI PHARMS2004-04-2315
ANDA 202445AUROBINDO PHARMA2016-05-116
ANDA 205268GLENMARK PHARMS LTD2017-09-086
ANDA 205956RISING2018-07-023
ANDA 210339SINOTHERAPEUTICS INC2019-01-043
ANDA 212744UPSHER SMITH LABS2020-06-253
ANDA 214184ZYDUS LIFESCIENCES2021-04-216
ANDA 213096AUROBINDO PHARMA LTD2023-02-213

Official labeling on DailyMed

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.