FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
71335-2655
11-digit product format
713352655
Labeler code
71335
Product ID
71335-2655_142e3bd5-63ba-4882-86c5-94649daa52f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flecainide acetate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210683
Marketing category
ANDA
Marketing start
2024-01-11
Substance
FLECAINIDE ACETATE
Active strength
150 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 ACETATE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM8U465Q1WQ
Rxcui886671

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
71335-2655-1Flecainide Acetate30 in 1 BOTTLETABLET301
71335-2655-2Flecainide Acetate90 in 1 BOTTLETABLET901
71335-2655-3Flecainide Acetate60 in 1 BOTTLETABLET601
71335-2655-4Flecainide Acetate180 in 1 BOTTLETABLET1801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886671flecainide acetate 150 MG Oral TabletPSNbf810a3b-1a71-4a05-bf54-d5a6caba444b1
886671flecainide acetate 150 MG Oral TabletSCDbf810a3b-1a71-4a05-bf54-d5a6caba444b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2655-17133526550130 TABLET in 1 BOTTLE (71335-2655-1) 30 tablet2025-06-23NoNoHistorical
71335-2655-27133526550290 TABLET in 1 BOTTLE (71335-2655-2) 90 tablet2025-06-23NoNoHistorical
71335-2655-37133526550360 TABLET in 1 BOTTLE (71335-2655-3) 60 tablet2025-06-23NoNoHistorical
71335-2655-471335265504180 TABLET in 1 BOTTLE (71335-2655-4) 180 tablet2025-06-23NoNoHistorical