FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
71335-3063
11-digit product format
713353063
Labeler code
71335
Product ID
71335-3063_89eba7bc-b9e6-4132-901c-7c95963039e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flecainide acetate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215599
Marketing category
ANDA
Marketing start
2022-09-15
Substance
FLECAINIDE ACETATE
Active strength
100 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Flecainide Acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLECAINIDE ACETATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM8U465Q1WQ
Rxcui886666

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
71335-3063-1Flecainide Acetate30 in 1 BOTTLETABLET301
71335-3063-2Flecainide Acetate60 in 1 BOTTLETABLET601
71335-3063-3Flecainide Acetate90 in 1 BOTTLETABLET901
71335-3063-4Flecainide Acetate180 in 1 BOTTLETABLET1801
71335-3063-5Flecainide Acetate100 in 1 BOTTLETABLET1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886666flecainide acetate 100 MG Oral TabletPSN8a900f29-85e1-464c-ae9e-44dc7cf11f461
886666flecainide acetate 100 MG Oral TabletSCD8a900f29-85e1-464c-ae9e-44dc7cf11f461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3063-17133530630130 TABLET in 1 BOTTLE (71335-3063-1) 30 tablet2026-02-06NoNoHistorical
71335-3063-27133530630260 TABLET in 1 BOTTLE (71335-3063-2) 60 tablet2026-02-06NoNoHistorical
71335-3063-37133530630390 TABLET in 1 BOTTLE (71335-3063-3) 90 tablet2026-02-06NoNoHistorical
71335-3063-471335306304180 TABLET in 1 BOTTLE (71335-3063-4) 180 tablet2026-02-06NoNoHistorical
71335-3063-571335306305100 TABLET in 1 BOTTLE (71335-3063-5) 100 tablet2026-02-06NoNoHistorical