FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
65162-642
11-digit product format
651620642
Labeler code
65162
Product ID
65162-642_2d832566-4d97-4605-a207-04c4a0214213
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flecainide Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA075442
Marketing category
ANDA
Marketing start
2009-12-01
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
65162-642-10Flecainide Acetate100 in 1 BOTTLETABLET10016
65162-642-11Flecainide Acetate1000 in 1 BOTTLETABLET100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-642-10EA - Each65162-64280b69335-3f0a-4852-bafe-afb22866194412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLECAINIDE ACETATEACTIVE INGREDIENTM8U465Q1WQFLECAINIDE ACETATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8
FLECAINIDEACTIVE MOIETYK94FTS1806FLECAINIDE ACETATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-642FLECAINIDE ACETATE TABLET [AMNEAL PHARMACEUTICALS LLC]16Current NDC, Legacy NDC, 2 package rows20241027_d462d58e-fc3c-4c92-a210-e135eb1f4b77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886666flecainide acetate 100 MG Oral TabletPSNd462d58e-fc3c-4c92-a210-e135eb1f4b7716
886671flecainide acetate 150 MG Oral TabletPSNd462d58e-fc3c-4c92-a210-e135eb1f4b7716
886662flecainide acetate 50 MG Oral TabletPSNd462d58e-fc3c-4c92-a210-e135eb1f4b7716
886666flecainide acetate 100 MG Oral TabletSCDd462d58e-fc3c-4c92-a210-e135eb1f4b7716
886671flecainide acetate 150 MG Oral TabletSCDd462d58e-fc3c-4c92-a210-e135eb1f4b7716
886662flecainide acetate 50 MG Oral TabletSCDd462d58e-fc3c-4c92-a210-e135eb1f4b7716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-642-1065162064210100 TABLET in 1 BOTTLE (65162-642-10) 100 tablet2009-12-010000-00-00NoNoCurrent
65162-642-11651620642111000 TABLET in 1 BOTTLE (65162-642-11) 1000 tablet2009-12-010000-00-00NoNoCurrent