FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
62559-380
11-digit product format
625590380
Labeler code
62559
Product ID
62559-380_74b708a0-2859-4efd-98a6-0c2f04d20114
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flecainide Acetate Tablet
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA075882
Marketing category
ANDA
Marketing start
2015-12-28
Substance
FLECAINIDE ACETATE
Active strength
50 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLECAINIDE ACETATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM8U465Q1WQ
Rxcui886662, 886666, 886671

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
47936aaf-dd8f-a65f-335e-74a6c45bbd64Product name520231128

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-380-01Flecainide Acetate100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-380-01EA - Each62559-380870c5f8f-5f01-42e5-b767-a59952f58d5912016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-380FLECAINIDE ACETATE (FLECAINIDE ACETATE TABLET) TABLET [ANI PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20230727_5a12889a-52ce-4dc4-9240-22d126f071ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886662flecainide acetate 50 MG Oral TabletPSN9929c166-8ba3-4159-a5f9-4618d5d227b0103
886662flecainide acetate 50 MG Oral TabletPSN5dc5b522-f16f-4b3b-b325-f4ace495f966103
886662flecainide acetate 50 MG Oral TabletSCD9929c166-8ba3-4159-a5f9-4618d5d227b0103
886662flecainide acetate 50 MG Oral TabletSCD5dc5b522-f16f-4b3b-b325-f4ace495f966103
886662flecainide acetate 50 MG Oral TabletPSNd34fae51-3658-4456-b3ea-1217f0f52260101
886662flecainide acetate 50 MG Oral TabletSCDd34fae51-3658-4456-b3ea-1217f0f52260101
886666flecainide acetate 100 MG Oral TabletPSN74355cd2-b50e-0dc2-e053-2a91aa0aa16410
886671flecainide acetate 150 MG Oral TabletPSN74355cd2-b50e-0dc2-e053-2a91aa0aa16410
886662flecainide acetate 50 MG Oral TabletPSN74355cd2-b50e-0dc2-e053-2a91aa0aa16410
886666flecainide acetate 100 MG Oral TabletSCD74355cd2-b50e-0dc2-e053-2a91aa0aa16410
886671flecainide acetate 150 MG Oral TabletSCD74355cd2-b50e-0dc2-e053-2a91aa0aa16410
886662flecainide acetate 50 MG Oral TabletSCD74355cd2-b50e-0dc2-e053-2a91aa0aa16410
886666flecainide acetate 100 MG Oral TabletPSN5a12889a-52ce-4dc4-9240-22d126f071ac7
886671flecainide acetate 150 MG Oral TabletPSN5a12889a-52ce-4dc4-9240-22d126f071ac7
886662flecainide acetate 50 MG Oral TabletPSN5a12889a-52ce-4dc4-9240-22d126f071ac7
886666flecainide acetate 100 MG Oral TabletSCD5a12889a-52ce-4dc4-9240-22d126f071ac7
886671flecainide acetate 150 MG Oral TabletSCD5a12889a-52ce-4dc4-9240-22d126f071ac7
886662flecainide acetate 50 MG Oral TabletSCD5a12889a-52ce-4dc4-9240-22d126f071ac7
886662flecainide acetate 50 MG Oral TabletPSNf0416c8c-faae-4e31-aa50-1fb7df10abf05
886662flecainide acetate 50 MG Oral TabletSCDf0416c8c-faae-4e31-aa50-1fb7df10abf05
886662flecainide acetate 50 MG Oral TabletPSN179e3821-0342-4b84-96bb-3fcab213d74f3
886662flecainide acetate 50 MG Oral TabletSCD179e3821-0342-4b84-96bb-3fcab213d74f3
886662flecainide acetate 50 MG Oral TabletPSNee590951-cce8-4a1e-b3bd-ae0b610ebda91
886662flecainide acetate 50 MG Oral TabletSCDee590951-cce8-4a1e-b3bd-ae0b610ebda91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-380-0162559038001100 TABLET in 1 BOTTLE (62559-380-01) 100 tablet2015-12-280000-00-00NoNoCurrent