NDC 0069-5820

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 ID: 0069-5820_5e39d293-2756-4e4e-9791-898f127ba113
• NDC: 0069-5820
• Product Type: Human Prescription Drug
• Proprietary Name: Tikosyn
• Generic Name: Dofetilide
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1999-10-01
• Marketing Category: NDA / NDA
• Application Number: NDA020931
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: DOFETILIDE
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Antiarrhythmic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0069-5820-43

40 BLISTER PACK in 1 CARTON (0069-5820-43) > 1 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 1999-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-5820-43 [00069582043]

Tikosyn CAPSULE

• Marketing Category: NDA
• Application Number: NDA020931
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-10-01

NDC 0069-5820-61 [00069582061]

Tikosyn CAPSULE

• Marketing Category: NDA
• Application Number: NDA020931
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-10-01

NDC 0069-5820-60 [00069582060]

Tikosyn CAPSULE

• Marketing Category: NDA
• Application Number: NDA020931
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-10-01

Drug Details

Active Ingredients

Ingredient	Strength
DOFETILIDE	.5 mg/1

OpenFDA Data

• SPL SET ID: 02438044-d6a3-49e9-a1ac-3aad21ef2c8c
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • R4Z9X1N2ND
• 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"

NDC	Brand Name	Generic Name
0069-5800	Tikosyn	dofetilide
0069-5810	Tikosyn	dofetilide
0069-5820	Tikosyn	dofetilide
69189-5800	Tikosyn	Tikosyn
69189-5810	Tikosyn	Tikosyn
69189-5820	Tikosyn	Tikosyn
0904-6681	Dofetilide	Dofetilide
0904-6682	Dofetilide	Dofetilide
0904-6683	Dofetilide	Dofetilide
16714-840	Dofetilide	Dofetilide
16714-841	Dofetilide	Dofetilide
16714-842	Dofetilide	Dofetilide
16729-490	Dofetilide	Dofetilide
16729-491	Dofetilide	Dofetilide
16729-492	Dofetilide	Dofetilide
42291-411	Dofetilide	Dofetilide
42291-412	Dofetilide	Dofetilide
42291-413	Dofetilide	Dofetilide