NDC 0591-0583

Propafenone HCl

Propafenone Hydrochloride

Propafenone HCl is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Propafenone Hydrochloride.

Product ID0591-0583_71d5cee6-245f-4d4a-8a59-e555c3ca4573
NDC0591-0583
Product TypeHuman Prescription Drug
Proprietary NamePropafenone HCl
Generic NamePropafenone Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2000-10-24
Marketing CategoryANDA / ANDA
Application NumberANDA075203
Labeler NameActavis Pharma, Inc.
Substance NamePROPAFENONE HYDROCHLORIDE
Active Ingredient Strength225 mg/1
Pharm ClassesAntiarrhythmic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0591-0583-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0583-01)
Marketing Start Date2000-10-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-0583-05 [00591058305]

Propafenone HCl TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075203
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-10-24
Marketing End Date2013-07-17

NDC 0591-0583-01 [00591058301]

Propafenone HCl TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075203
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-10-24

Drug Details

Active Ingredients

IngredientStrength
PROPAFENONE HYDROCHLORIDE225 mg/1

OpenFDA Data

SPL SET ID:a313c111-e539-47bc-9d57-c3767f74bcca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861424
  • 861427

    • Pharmacological Class

    • Antiarrhythmic [EPC]
    • Antiarrhythmic [EPC]

    NDC Crossover Matching brand name "Propafenone HCl" or generic name "Propafenone Hydrochloride"

    NDCBrand NameGeneric Name
    0591-0582Propafenone HClPropafenone hydrochloride
    0591-0583Propafenone HClPropafenone hydrochloride
    68084-361Propafenone HClPropafenone HCl
    50090-2975Propafenone HClPropafenone HCl
    63739-510Propafenone HClPropafenone HCl
    63739-509Propafenone HClPropafenone HCl
    0591-2285Propafenone HydrochloridePropafenone Hydrochloride
    0591-2286Propafenone HydrochloridePropafenone Hydrochloride
    0591-2287Propafenone HydrochloridePropafenone Hydrochloride
    0603-5448Propafenone HydrochloridePropafenone Hydrochloride
    0603-5449Propafenone HydrochloridePropafenone Hydrochloride
    0603-5450Propafenone HydrochloridePropafenone Hydrochloride
    0615-7574Propafenone HydrochloridePropafenone Hydrochloride
    0832-0740Propafenone HydrochloridePropafenone Hydrochloride
    0832-0741Propafenone HydrochloridePropafenone Hydrochloride
    0832-0742Propafenone HydrochloridePropafenone Hydrochloride
    16571-736PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE
    16571-737PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE
    0173-0823RYTHMOLpropafenone hydrochloride
    0173-0824RYTHMOLpropafenone hydrochloride
    0173-0826RYTHMOLpropafenone hydrochloride
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