FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
71335-2577
11-digit product format
713352577
Labeler code
71335
Product ID
71335-2577_d1f9c698-47c7-46f7-9e8a-f31610f0e6cf
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
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
71335-2577-1Flecainide Acetate30 in 1 BOTTLETABLET302
71335-2577-2Flecainide Acetate60 in 1 BOTTLETABLET602
71335-2577-3Flecainide Acetate90 in 1 BOTTLETABLET902
71335-2577-4Flecainide Acetate180 in 1 BOTTLETABLET1802
71335-2577-5Flecainide Acetate100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2577-3EA - Each71335-25773101c096-e427-490e-afe2-ce8560fa1e6412026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2577FLECAINIDE ACETATE TABLET [BRYANT RANCH PREPACK]1Current NDC, 5 package rows20250207_a30103c5-a261-49a5-a7b3-f43eb77e87b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886666flecainide acetate 100 MG Oral TabletPSNa30103c5-a261-49a5-a7b3-f43eb77e87b72
886666flecainide acetate 100 MG Oral TabletSCDa30103c5-a261-49a5-a7b3-f43eb77e87b72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2577-17133525770130 TABLET in 1 BOTTLE (71335-2577-1) 30 tablet2025-02-05NoNoHistorical
71335-2577-27133525770260 TABLET in 1 BOTTLE (71335-2577-2) 60 tablet2025-02-05NoNoHistorical
71335-2577-37133525770390 TABLET in 1 BOTTLE (71335-2577-3) 90 tablet2025-02-05NoNoHistorical
71335-2577-471335257704180 TABLET in 1 BOTTLE (71335-2577-4) 180 tablet2025-02-05NoNoHistorical
71335-2577-571335257705100 TABLET in 1 BOTTLE (71335-2577-5) 100 tablet2025-02-05NoNoHistorical