FDA.reportPublic FDA data

Dofetilide

Product NDC
72205-040
11-digit product format
722050040
Labeler code
72205
Product ID
72205-040_feb8626e-9d88-4a06-919f-f8169a69814b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dofetilide
Dosage form
CAPSULE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA213220
Marketing category
ANDA
Marketing start
2020-06-12
Substance
DOFETILIDE
Active strength
.25 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A213220-001DOFETILIDEDOFETILIDE0.125MGCAPSULE / ORALAB2020-01-29
A213220-002DOFETILIDEDOFETILIDE0.25MGCAPSULE / ORALAB2020-01-29
A213220-003DOFETILIDEDOFETILIDE0.5MGCAPSULE / ORALAB2020-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213220-001AB
A213220-002AB
A213220-003AB

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 22:54:322026-06A213220-001DOFETILIDE0.125MGCAPSULE / ORALAB2020-01-29a50c72e98297…
2026-08-01 22:54:322026-06A213220-002DOFETILIDE0.25MGCAPSULE / ORALAB2020-01-29a50c72e98297…
2026-08-01 22:54:322026-06A213220-003DOFETILIDE0.5MGCAPSULE / ORALAB2020-01-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213220-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A213220-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A213220-003AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DofetilideDOFETILIDEREMEDYREPACK INC.a5d943c6-1960-4318-9e6f-6bf69ac499532026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213220
application number: ANDA213220
DofetilideDOFETILIDENovadoz Pharmaceuticals LLCb8323987-90fe-4e6c-a71c-76e3c501713c2022-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213220
application number: ANDA213220
ndc (product): 72205-040

Additional Listing Data#

Finished product
Yes
Brand name base
Dofetilide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOFETILIDE.25 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
b8323987-90fe-4e6c-a71c-76e3c501713cAvailable 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
72205-040-11Dofetilide10 in 1 BLISTER PACKCAPSULE102
72205-040-37Dofetilide4 in 1 CARTONCAPSULE42
72205-040-60Dofetilide60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-040-60EA - Each72205-0405a04becb-fd48-4808-bb5f-58e3132a8e8012020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-040DOFETILIDE CAPSULE [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 3 package rows20220731_b8323987-90fe-4e6c-a71c-76e3c501713c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310003dofetilide 125 MCG Oral CapsulePSNb8323987-90fe-4e6c-a71c-76e3c501713c2
310004dofetilide 250 MCG Oral CapsulePSNb8323987-90fe-4e6c-a71c-76e3c501713c2
310005dofetilide 500 MCG Oral CapsulePSNb8323987-90fe-4e6c-a71c-76e3c501713c2
310003dofetilide 0.125 MG Oral CapsuleSCDb8323987-90fe-4e6c-a71c-76e3c501713c2
310004dofetilide 0.25 MG Oral CapsuleSCDb8323987-90fe-4e6c-a71c-76e3c501713c2
310005dofetilide 0.5 MG Oral CapsuleSCDb8323987-90fe-4e6c-a71c-76e3c501713c2
310003dofetilide 125 MCG Oral CapsuleSYb8323987-90fe-4e6c-a71c-76e3c501713c2
310004dofetilide 250 MCG Oral CapsuleSYb8323987-90fe-4e6c-a71c-76e3c501713c2
310005dofetilide 500 MCG Oral CapsuleSYb8323987-90fe-4e6c-a71c-76e3c501713c2
310004dofetilide 250 MCG Oral CapsulePSNa5d943c6-1960-4318-9e6f-6bf69ac499531
310004dofetilide 0.25 MG Oral CapsuleSCDa5d943c6-1960-4318-9e6f-6bf69ac499531
310004dofetilide 250 MCG Oral CapsuleSYa5d943c6-1960-4318-9e6f-6bf69ac499531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-040-117220500401110 in 1 BLISTER PACKHistorical
72205-040-37722050040374 BLISTER PACK in 1 CARTON (72205-040-37) / 10 CAPSULE in 1 BLISTER PACK (72205-040-11) 4 blister pack2020-06-120000-00-00NoNoCurrent
72205-040-607220500406060 CAPSULE in 1 BOTTLE (72205-040-60) 60 capsule2020-06-120000-00-00NoNoCurrent