NDC 0378-1259

Propafenone Hydrochloride

Propafenone

Propafenone Hydrochloride is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Propafenone Hydrochloride.

Product ID0378-1259_173fd954-8e93-4c80-b41d-60f12b19f275
NDC0378-1259
Product TypeHuman Prescription Drug
Proprietary NamePropafenone Hydrochloride
Generic NamePropafenone
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-05-23
Marketing CategoryANDA / ANDA
Application NumberANDA203803
Labeler NameMylan Pharmaceuticals Inc.
Substance NamePROPAFENONE HYDROCHLORIDE
Active Ingredient Strength325 mg/1
Pharm ClassesAntiarrhythmic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-1259-91

60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1259-91)
Marketing Start Date2016-05-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1259-91 [00378125991]

Propafenone Hydrochloride CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203803
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-23

NDC 0378-1259-05 [00378125905]

Propafenone Hydrochloride CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA203803
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-23
Marketing End Date2018-03-31

Drug Details

Active Ingredients

IngredientStrength
PROPAFENONE HYDROCHLORIDE325 mg/1

OpenFDA Data

SPL SET ID:49285d51-bcba-4879-930f-b5da4630160b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861164
  • 861171
  • 861156

    • Pharmacological Class

    • Antiarrhythmic [EPC]
    • Antiarrhythmic [EPC]

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

    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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