NDC 0069-5800

Tikosyn

Dofetilide

Tikosyn is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Dofetilide.

Product ID0069-5800_5e39d293-2756-4e4e-9791-898f127ba113
NDC0069-5800
Product TypeHuman Prescription Drug
Proprietary NameTikosyn
Generic NameDofetilide
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1999-10-01
Marketing CategoryNDA / NDA
Application NumberNDA020931
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameDOFETILIDE
Active Ingredient Strength0 mg/1
Pharm ClassesAntiarrhythmic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0069-5800-43

40 BLISTER PACK in 1 CARTON (0069-5800-43) > 1 CAPSULE in 1 BLISTER PACK
Marketing Start Date1999-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-5800-60 [00069580060]

Tikosyn CAPSULE
Marketing CategoryNDA
Application NumberNDA020931
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-10-01

NDC 0069-5800-43 [00069580043]

Tikosyn CAPSULE
Marketing CategoryNDA
Application NumberNDA020931
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-10-01

NDC 0069-5800-61 [00069580061]

Tikosyn CAPSULE
Marketing CategoryNDA
Application NumberNDA020931
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-10-01

Drug Details

Active Ingredients

IngredientStrength
DOFETILIDE.125 mg/1

OpenFDA Data

SPL SET ID:02438044-d6a3-49e9-a1ac-3aad21ef2c8c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310004
  • 310005
  • 310003
  • 285016
  • 284404
  • 284405
  • UPC Code
  • 0300695810602
  • 0300695820601
  • 0300695800603
  • Pharmacological Class

    • Antiarrhythmic [EPC]

    NDC Crossover Matching brand name "Tikosyn" or generic name "Dofetilide"

    NDCBrand NameGeneric Name
    0069-5800Tikosyndofetilide
    0069-5810Tikosyndofetilide
    0069-5820Tikosyndofetilide
    69189-5800TikosynTikosyn
    69189-5810TikosynTikosyn
    69189-5820TikosynTikosyn
    0904-6681DofetilideDofetilide
    0904-6682DofetilideDofetilide
    0904-6683DofetilideDofetilide
    16714-840DofetilideDofetilide
    16714-841DofetilideDofetilide
    16714-842DofetilideDofetilide
    16729-490DofetilideDofetilide
    16729-491DofetilideDofetilide
    16729-492DofetilideDofetilide
    42291-411DofetilideDofetilide
    42291-412DofetilideDofetilide
    42291-413DofetilideDofetilide

    Trademark Results [Tikosyn]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TIKOSYN
    TIKOSYN
    75320488 2375648 Live/Registered
    Pfizer Inc.
    1997-07-07

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