FDA.reportPublic FDA data

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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0069-58200069-5820-43DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020931-001TIKOSYNDOFETILIDE0.125MGCAPSULE / ORALABRLD1999-10-01
N020931-002TIKOSYNDOFETILIDE0.25MGCAPSULE / ORALABRLD1999-10-01
N020931-003TIKOSYNDOFETILIDE0.5MGCAPSULE / ORALABRLD, RS1999-10-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N020931-001AB
N020931-002AB
N020931-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020931-001TIKOSYN0.125MGCAPSULE / ORALABRLD1999-10-01a50c72e98297…
2026-08-01 22:54:322026-06N020931-002TIKOSYN0.25MGCAPSULE / ORALABRLD1999-10-01a50c72e98297…
2026-08-01 22:54:322026-06N020931-003TIKOSYN0.5MGCAPSULE / ORALABRLD, RS1999-10-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020931-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N020931-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N020931-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TikosynDOFETILIDEPfizer Laboratories Div Pfizer Inc02438044-d6a3-49e9-a1ac-3aad21ef2c8c2026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020931
application number: NDA020931
ndc (product): 0069-5820

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R4Z9X1N2NDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
284404Internal RxNorm lookup
284405Internal RxNorm lookup
285016Internal RxNorm lookup
310003Internal RxNorm lookup
310004Internal RxNorm lookup
310005Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
02438044-d6a3-49e9-a1ac-3aad21ef2c8cAvailable on FDA.report

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOFETILIDEACTIVE INGREDIENTR4Z9X1N2NDTIKOSYN (DOFETILIDE) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]10
DOFETILIDEACTIVE MOIETYR4Z9X1N2NDTIKOSYN (DOFETILIDE) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIKOSYN (DOFETILIDE) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TIKOSYN (DOFETILIDE) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIKOSYN (DOFETILIDE) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTIKOSYN (DOFETILIDE) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]10

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