FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
71335-2995
11-digit product format
713352995
Labeler code
71335
Product ID
71335-2995_7f3745b5-2c12-438a-bbdb-32e1803b73f3
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
50 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 ACETATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM8U465Q1WQ
Rxcui886662

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
71335-2995-1Flecainide Acetate30 in 1 BOTTLETABLET301
71335-2995-2Flecainide Acetate60 in 1 BOTTLETABLET601
71335-2995-3Flecainide Acetate90 in 1 BOTTLETABLET901
71335-2995-4Flecainide Acetate10 in 1 BOTTLETABLET101
71335-2995-5Flecainide Acetate180 in 1 BOTTLETABLET1801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886662flecainide acetate 50 MG Oral TabletPSN5cfa10ba-dfe8-42ab-81b3-8cca657aba071
886662flecainide acetate 50 MG Oral TabletSCD5cfa10ba-dfe8-42ab-81b3-8cca657aba071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2995-17133529950130 TABLET in 1 BOTTLE (71335-2995-1) 30 tablet2026-02-04NoNoHistorical
71335-2995-27133529950260 TABLET in 1 BOTTLE (71335-2995-2) 60 tablet2026-02-04NoNoHistorical
71335-2995-37133529950390 TABLET in 1 BOTTLE (71335-2995-3) 90 tablet2026-02-04NoNoHistorical
71335-2995-47133529950410 TABLET in 1 BOTTLE (71335-2995-4) 10 tablet2026-02-04NoNoHistorical
71335-2995-571335299505180 TABLET in 1 BOTTLE (71335-2995-5) 180 tablet2026-02-04NoNoHistorical