NDC 0054-0011

Flecainide Acetate

Flecainide Acetate

Flecainide Acetate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Flecainide Acetate.

Product ID0054-0011_fb4e03f5-aaef-472e-8109-7726f6362c22
NDC0054-0011
Product TypeHuman Prescription Drug
Proprietary NameFlecainide Acetate
Generic NameFlecainide Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2003-01-14
Marketing CategoryANDA / ANDA
Application NumberANDA076278
Labeler NameWest-Ward Pharmaceuticals Corp.
Substance NameFLECAINIDE ACETATE
Active Ingredient Strength100 mg/1
Pharm ClassesAntiarrhythmic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0054-0011-20

100 BLISTER PACK in 1 CARTON (0054-0011-20) > 1 TABLET in 1 BLISTER PACK
Marketing Start Date2003-01-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0011-25 [00054001125]

Flecainide Acetate TABLET
Marketing CategoryANDA
Application NumberANDA076278
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-01-14

NDC 0054-0011-21 [00054001121]

Flecainide Acetate TABLET
Marketing CategoryANDA
Application NumberANDA076278
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-01-14

NDC 0054-0011-20 [00054001120]

Flecainide Acetate TABLET
Marketing CategoryANDA
Application NumberANDA076278
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-01-14

Drug Details

Active Ingredients

IngredientStrength
FLECAINIDE ACETATE100 mg/1

OpenFDA Data

SPL SET ID:4f6b78d4-8ac8-464b-bb78-ee70cbc97898
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 886662
  • 886671
  • 886666
  • UPC Code
  • 0300540012212
  • 0300540011215
  • Pharmacological Class

    • Antiarrhythmic [EPC]
    • Antiarrhythmic [EPC]

    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

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