Tikosyn

Product NDC
0069-5810
11-digit product format
000695810
Labeler code
0069
Product ID
0069-5810_0109bfef-980f-4bc8-a802-3d3c45587456
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dofetilide
Dosage form
CAPSULE
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA020931
Marketing category
NDA
Marketing start
1999-10-01
Substance
DOFETILIDE
Active strength
.25 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tikosyn
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOFETILIDE.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR4Z9X1N2ND
Rxcui284404, 284405, 285016, 310003, 310004, 310005

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc36b95-20ce-9079-16ec-f3cdb4dcf4fdProduct name920230112

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-5810-43Tikosyn1 in 1 BLISTER PACKCAPSULE130
0069-5810-43Tikosyn40 in 1 CARTONCAPSULE4030
0069-5810-60Tikosyn60 in 1 BOTTLECAPSULE6030
0069-5810-61Tikosyn14 in 1 BOTTLECAPSULE1430

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-5810-43EA - Each0069-5810482764c3-2b90-4890-baa6-2d8a707f60bb12012-07-24
0069-5810-60EA - Each0069-5810441ac37a-b077-4de0-8c2c-4b926689eca412012-07-24
0069-5810-61EA - Each0069-581037fc2725-ba22-4b3e-9175-85894da5374d12013-08-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-5810TIKOSYN (DOFETILIDE) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]29Current NDC, Legacy NDC, 4 package rows20250212_02438044-d6a3-49e9-a1ac-3aad21ef2c8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310003dofetilide 125 MCG Oral CapsulePSN02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
310004dofetilide 250 MCG Oral CapsulePSN02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
310005dofetilide 500 MCG Oral CapsulePSN02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
284404Tikosyn 125 MCG Oral CapsulePSN02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
284405Tikosyn 250 MCG Oral CapsulePSN02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
285016Tikosyn 500 MCG Oral CapsulePSN02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
284404dofetilide 0.125 MG Oral Capsule [Tikosyn]SBD02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
284405dofetilide 0.25 MG Oral Capsule [Tikosyn]SBD02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
285016dofetilide 0.5 MG Oral Capsule [Tikosyn]SBD02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
310003dofetilide 0.125 MG Oral CapsuleSCD02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
310004dofetilide 0.25 MG Oral CapsuleSCD02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
310005dofetilide 0.5 MG Oral CapsuleSCD02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
310003dofetilide 125 MCG Oral CapsuleSY02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
310004dofetilide 250 MCG Oral CapsuleSY02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
310005dofetilide 500 MCG Oral CapsuleSY02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
284404Tikosyn 0.125 MG Oral CapsuleSY02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
284405Tikosyn 0.25 MG Oral CapsuleSY02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
285016Tikosyn 0.5 MG Oral CapsuleSY02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
284404Tikosyn 125 MCG Oral CapsuleSY02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
284405Tikosyn 250 MCG Oral CapsuleSY02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
285016Tikosyn 500 MCG Oral CapsuleSY02438044-d6a3-49e9-a1ac-3aad21ef2c8c30
310004dofetilide 250 MCG Oral CapsulePSN01f9fb69-2438-481c-b5ec-adebe78252531
284405Tikosyn 250 MCG Oral CapsulePSN01f9fb69-2438-481c-b5ec-adebe78252531
284405dofetilide 0.25 MG Oral Capsule [Tikosyn]SBD01f9fb69-2438-481c-b5ec-adebe78252531
310004dofetilide 0.25 MG Oral CapsuleSCD01f9fb69-2438-481c-b5ec-adebe78252531
310004dofetilide 250 MCG Oral CapsuleSY01f9fb69-2438-481c-b5ec-adebe78252531
284405Tikosyn 0.25 MG Oral CapsuleSY01f9fb69-2438-481c-b5ec-adebe78252531
284405Tikosyn 250 MCG Oral CapsuleSY01f9fb69-2438-481c-b5ec-adebe78252531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-5810-430006958104340 BLISTER PACK in 1 CARTON (0069-5810-43) > 1 CAPSULE in 1 BLISTER PACK40 blister pack1999-10-010000-00-00NoNoCurrent
0069-5810-600006958106060 CAPSULE in 1 BOTTLE (0069-5810-60) 60 capsule1999-10-010000-00-00NoNoCurrent
0069-5810-610006958106114 CAPSULE in 1 BOTTLE (0069-5810-61) 14 capsule1999-10-010000-00-00NoNoCurrent