FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
71335-2523
11-digit product format
713352523
Labeler code
71335
Product ID
71335-2523_b840330d-c2a7-4b52-83f2-d935e0f3f00e
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
150 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 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
71335-2523-1Flecainide Acetate30 in 1 BOTTLETABLET302
71335-2523-2Flecainide Acetate90 in 1 BOTTLETABLET902
71335-2523-3Flecainide Acetate60 in 1 BOTTLETABLET602
71335-2523-4Flecainide Acetate180 in 1 BOTTLETABLET1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2523FLECAINIDE ACETATE TABLET [BRYANT RANCH PREPACK]1Current NDC, 4 package rows20241127_b821ec16-93ff-4569-9fbb-4f3842c58bec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886671flecainide acetate 150 MG Oral TabletPSNb821ec16-93ff-4569-9fbb-4f3842c58bec2
886671flecainide acetate 150 MG Oral TabletSCDb821ec16-93ff-4569-9fbb-4f3842c58bec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2523-17133525230130 TABLET in 1 BOTTLE (71335-2523-1) 30 tablet2024-11-25NoNoHistorical
71335-2523-27133525230290 TABLET in 1 BOTTLE (71335-2523-2) 90 tablet2024-11-25NoNoHistorical
71335-2523-37133525230360 TABLET in 1 BOTTLE (71335-2523-3) 60 tablet2024-11-25NoNoHistorical
71335-2523-471335252304180 TABLET in 1 BOTTLE (71335-2523-4) 180 tablet2024-11-25NoNoHistorical