Tikosyn

Product NDC
0069-5820
11-digit product format
000695820
Labeler code
0069
Product ID
0069-5820_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
.5 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.5 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
0069-5820-43Tikosyn40 in 1 CARTONCAPSULE4030
0069-5820-43Tikosyn1 in 1 BLISTER PACKCAPSULE130
0069-5820-60Tikosyn60 in 1 BOTTLECAPSULE6030
0069-5820-61Tikosyn14 in 1 BOTTLECAPSULE1430

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-5820-43EA - Each0069-5820e8196247-4099-4117-97fe-f65ef41cf43312012-07-24
0069-5820-60EA - Each0069-58204f9d378e-7552-432f-b761-8155efa8a5c412012-07-24
0069-5820-61EA - Each0069-5820abd31200-81c5-43c8-96e5-cafe211a854712014-05-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-5820TIKOSYN (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
310005dofetilide 500 MCG Oral CapsulePSNb77b4388-36ec-4971-90a5-353879adb8b51
285016Tikosyn 500 MCG Oral CapsulePSNb77b4388-36ec-4971-90a5-353879adb8b51
285016dofetilide 0.5 MG Oral Capsule [Tikosyn]SBDb77b4388-36ec-4971-90a5-353879adb8b51
310005dofetilide 0.5 MG Oral CapsuleSCDb77b4388-36ec-4971-90a5-353879adb8b51
310005dofetilide 500 MCG Oral CapsuleSYb77b4388-36ec-4971-90a5-353879adb8b51
285016Tikosyn 0.5 MG Oral CapsuleSYb77b4388-36ec-4971-90a5-353879adb8b51
285016Tikosyn 500 MCG Oral CapsuleSYb77b4388-36ec-4971-90a5-353879adb8b51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-5820-430006958204340 BLISTER PACK in 1 CARTON (0069-5820-43) > 1 CAPSULE in 1 BLISTER PACK40 blister pack1999-10-010000-00-00NoNoCurrent
0069-5820-600006958206060 CAPSULE in 1 BOTTLE (0069-5820-60) 60 capsule1999-10-010000-00-00NoNoCurrent
0069-5820-610006958206114 CAPSULE in 1 BOTTLE (0069-5820-61) 14 capsule1999-10-010000-00-00NoNoCurrent