NDC 0603-5450

Propafenone Hydrochloride

Propafenone Hydrochloride

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

Product ID0603-5450_457767b9-94d0-48e9-a955-b32ff26b0cda
NDC0603-5450
Product TypeHuman Prescription Drug
Proprietary NamePropafenone Hydrochloride
Generic NamePropafenone Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2002-10-17
Marketing CategoryANDA / ANDA
Application NumberANDA075938
Labeler NamePar Pharmaceutical, Inc.
Substance NamePROPAFENONE HYDROCHLORIDE
Active Ingredient Strength300 mg/1
Pharm ClassesAntiarrhythmic [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0603-5450-21

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5450-21)
Marketing Start Date2002-10-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0603-5450-21 [00603545021]

Propafenone Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075938
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-10-17

NDC 0603-5450-28 [00603545028]

Propafenone Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075938
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2002-10-17
Marketing End Date2016-03-31

NDC 0603-5450-32 [00603545032]

Propafenone Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075938
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2002-10-17
Marketing End Date2016-03-31

NDC 0603-5450-10 [00603545010]

Propafenone Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075938
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2002-10-17
Marketing End Date2016-03-31

Drug Details

Active Ingredients

IngredientStrength
PROPAFENONE HYDROCHLORIDE300 mg/1

OpenFDA Data

SPL SET ID:d4a552ce-f215-4ec7-b5dd-aee266ba9b08
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861430
  • 861424
  • 861427
    • UPC Code
  • 0306035448214
  • 0306035450217
  • 0306035449211

    • Pharmacological Class

    • Antiarrhythmic [EPC]

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

    NDCBrand NameGeneric Name
    0378-1258Propafenone Hydrochloridepropafenone
    0378-1259Propafenone Hydrochloridepropafenone
    0378-1261Propafenone Hydrochloridepropafenone
    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
    68084-917Propafenone HydrochloridePropafenone Hydrochloride
    68462-408propafenone hydrochloridepropafenone hydrochloride
    68462-410propafenone hydrochloridepropafenone hydrochloride
    68462-409propafenone hydrochloridepropafenone hydrochloride
    69680-131Propafenone HydrochloridePropafenone Hydrochloride
    69680-132Propafenone HydrochloridePropafenone Hydrochloride
    69680-130Propafenone HydrochloridePropafenone Hydrochloride
    16714-826propafenone hydrochloridepropafenone hydrochloride
    16714-825propafenone hydrochloridepropafenone hydrochloride
    16714-827propafenone hydrochloridepropafenone hydrochloride
    42291-546Propafenone HydrochloridePropafenone Hydrochloride
    42291-547Propafenone HydrochloridePropafenone Hydrochloride
    42291-545Propafenone HydrochloridePropafenone Hydrochloride
    49884-211Propafenone HydrochloridePropafenone Hydrochloride
    49884-113Propafenone HydrochloridePropafenone Hydrochloride
    49884-210Propafenone HydrochloridePropafenone Hydrochloride
    50090-2949PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE
    50090-4227Propafenone HydrochloridePropafenone Hydrochloride
    51407-015Propafenone HydrochloridePropafenone Hydrochloride
    51407-016Propafenone HydrochloridePropafenone Hydrochloride
    51407-017Propafenone HydrochloridePropafenone Hydrochloride
    52536-733PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE
    52536-735PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE
    52536-730PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE
    53489-553PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE
    53489-551PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE
    53489-552PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE
    60429-976Propafenone HydrochloridePropafenone Hydrochloride
    60429-437Propafenone HydrochloridePropafenone Hydrochloride
    60429-438Propafenone HydrochloridePropafenone Hydrochloride
    60687-185Propafenone HydrochloridePropafenone Hydrochloride
    62559-230Propafenone HydrochloridePropafenone Hydrochloride
    62559-232Propafenone HydrochloridePropafenone Hydrochloride
    62559-231Propafenone HydrochloridePropafenone Hydrochloride
    0591-0582Propafenone HClPropafenone hydrochloride
    0591-0583Propafenone HClPropafenone hydrochloride
    0173-0823RYTHMOLpropafenone hydrochloride
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