FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
62559-381
11-digit product format
625590381
Labeler code
62559
Product ID
62559-381_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
100 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 ACETATE100 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
62559-381-01Flecainide Acetate100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-381-01EA - Each62559-3810ec9e51f-e7a3-400c-a613-0439798a0d7d12016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-381FLECAINIDE 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
886666flecainide acetate 100 MG Oral TabletPSN8dc86db1-2a09-4625-80eb-ff6ce9de2d7a104
886666flecainide acetate 100 MG Oral TabletSCD8dc86db1-2a09-4625-80eb-ff6ce9de2d7a104
886666flecainide acetate 100 MG Oral TabletPSNcf143926-439b-4005-be0e-1e049b44c044101
886666flecainide acetate 100 MG Oral TabletSCDcf143926-439b-4005-be0e-1e049b44c044101
886666flecainide acetate 100 MG Oral TabletPSN1a2a5e08-2697-4a00-94fe-de07148acbd911
886666flecainide acetate 100 MG Oral TabletSCD1a2a5e08-2697-4a00-94fe-de07148acbd911
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-381-0162559038101100 TABLET in 1 BOTTLE (62559-381-01) 100 tablet2015-12-280000-00-00NoNoCurrent