NDC 0173-0826

RYTHMOL SR

Propafenone Hydrochloride

RYTHMOL SR is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Propafenone Hydrochloride.

Product ID0173-0826_017a458a-b8d9-4855-84ad-f57bf1a86c61
NDC0173-0826
Product TypeHuman Prescription Drug
Proprietary NameRYTHMOL SR
Generic NamePropafenone Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-03-17
Marketing CategoryNDA / NDA
Application NumberNDA021416
Labeler NameGlaxoSmithKline LLC
Substance NamePROPAFENONE HYDROCHLORIDE
Active Ingredient Strength425 mg/1
Pharm ClassesAntiarrhythmic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0173-0826-18

60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0173-0826-18)
Marketing Start Date2011-03-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0173-0826-18 [00173082618]

RYTHMOL SR CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021416
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-03-17

Drug Details

Active Ingredients

IngredientStrength
PROPAFENONE HYDROCHLORIDE425 mg/1

OpenFDA Data

SPL SET ID:8bb1bc4a-a019-49c8-af81-be899822428f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861164
  • 861173
  • 861171
  • 861167
  • 861159
  • 861156
  • UPC Code
  • 0301730823182
  • 0301730824189
  • 0301730826183
  • Pharmacological Class

    • Antiarrhythmic [EPC]

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

    NDCBrand NameGeneric Name
    0591-0582Propafenone HClPropafenone hydrochloride
    0591-0583Propafenone HClPropafenone hydrochloride
    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

    Trademark Results [RYTHMOL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RYTHMOL
    RYTHMOL
    73652891 1480413 Live/Registered
    HELOPHARM W. PETRIK GMBH & CO. KG
    1987-04-03

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.