NDC 65162-643

Flecainide Acetate

Flecainide Acetate

Flecainide Acetate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Flecainide Acetate.

Product ID65162-643_635f1a25-acf1-4242-ade0-8bf91ff54c52
NDC65162-643
Product TypeHuman Prescription Drug
Proprietary NameFlecainide Acetate
Generic NameFlecainide Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA075442
Labeler NameAmneal Pharmaceuticals LLC
Substance NameFLECAINIDE ACETATE
Active Ingredient Strength150 mg/1
Pharm ClassesAntiarrhythmic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65162-643-10

100 TABLET in 1 BOTTLE (65162-643-10)
Marketing Start Date2009-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-643-10 [65162064310]

Flecainide Acetate TABLET
Marketing CategoryANDA
Application NumberANDA075442
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-12-01

NDC 65162-643-11 [65162064311]

Flecainide Acetate TABLET
Marketing CategoryANDA
Application NumberANDA075442
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-12-01

Drug Details

Active Ingredients

IngredientStrength
FLECAINIDE ACETATE150 mg/1

OpenFDA Data

SPL SET ID:d462d58e-fc3c-4c92-a210-e135eb1f4b77
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 886662
  • 886671
  • 886666
  • UPC Code
  • 0365162643107
  • 0365162641103
  • 0365162642100
  • Pharmacological Class

    • Antiarrhythmic [EPC]

    Medicade Reported Pricing

    65162064310 FLECAINIDE ACETATE 150 MG TAB

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Flecainide Acetate" or generic name "Flecainide Acetate"

    NDCBrand NameGeneric Name
    0054-0010Flecainide Acetateflecainide acetate
    0054-0011Flecainide Acetateflecainide acetate
    0054-0012Flecainide Acetateflecainide acetate
    0179-0201Flecainide Acetateflecainide acetate
    0179-0231Flecainide AcetateFlecainide Acetate Tablet
    42291-293Flecainide AcetateFlecainide Acetate
    42291-294Flecainide AcetateFlecainide Acetate
    42291-295Flecainide AcetateFlecainide Acetate
    42806-817Flecainide Acetateflecainide acetate
    42806-818Flecainide Acetateflecainide acetate
    42806-819Flecainide Acetateflecainide acetate
    43199-056Flecainide acetateFlecainide acetate
    43199-057Flecainide acetateFlecainide acetate
    43199-058Flecainide acetateFlecainide acetate
    50090-1132Flecainide Acetateflecainide acetate
    50090-1133Flecainide AcetateFlecainide Acetate
    50090-2233Flecainide AcetateFlecainide Acetate
    50090-2968Flecainide AcetateFlecainide Acetate
    50090-5267Flecainide AcetateFlecainide Acetate
    50090-5306Flecainide AcetateFlecainide Acetate
    50090-6035Flecainide AcetateFlecainide Acetate
    50268-320Flecainide AcetateFlecainide Acetate
    50268-321Flecainide AcetateFlecainide Acetate
    50268-322Flecainide AcetateFlecainide Acetate
    51407-018Flecainide AcetateFlecainide Acetate Tablet
    51407-019Flecainide AcetateFlecainide Acetate Tablet
    51407-020Flecainide AcetateFlecainide Acetate Tablet
    68151-1464Flecainide AcetateFlecainide Acetate
    53746-641Flecainide AcetateFlecainide Acetate
    53746-643Flecainide AcetateFlecainide Acetate
    53746-642Flecainide AcetateFlecainide Acetate
    57237-063Flecainide AcetateFlecainide Acetate
    57237-065Flecainide AcetateFlecainide Acetate
    57237-064Flecainide AcetateFlecainide Acetate
    60687-225Flecainide AcetateFlecainide Acetate
    62559-382Flecainide AcetateFlecainide Acetate
    62559-380Flecainide AcetateFlecainide Acetate
    62559-381Flecainide AcetateFlecainide Acetate
    63304-795Flecainide AcetateFlecainide Acetate
    63304-794Flecainide AcetateFlecainide Acetate
    63304-796Flecainide AcetateFlecainide Acetate
    65162-643Flecainide AcetateFlecainide Acetate
    65162-641Flecainide AcetateFlecainide Acetate
    65862-621Flecainide AcetateFlecainide Acetate
    65162-642Flecainide AcetateFlecainide Acetate
    65862-622Flecainide AcetateFlecainide Acetate
    65862-623Flecainide AcetateFlecainide Acetate
    63629-7979Flecainide AcetateFlecainide Acetate
    63629-7982Flecainide AcetateFlecainide Acetate

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