Flecainide Acetate

Product NDC
63629-1981
11-digit product format
636291981
Labeler code
63629
Product ID
63629-1981_f2b5a016-df67-45ce-933e-b1f39c8aa6d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flecainide Acetate Tablet
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075882
Marketing category
ANDA
Marketing start
2015-12-28
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
63629-1981-1Flecainide Acetate100 in 1 BOTTLETABLET100103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1981FLECAINIDE ACETATE (FLECAINIDE ACETATE TABLET) TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20231110_2028149f-6fc0-455c-bac5-729eeaa4aee5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886671flecainide acetate 150 MG Oral TabletPSN2028149f-6fc0-455c-bac5-729eeaa4aee5103
886671flecainide acetate 150 MG Oral TabletSCD2028149f-6fc0-455c-bac5-729eeaa4aee5103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1981-163629198101100 TABLET in 1 BOTTLE (63629-1981-1) 100 tablet2021-01-150000-00-00NoNoCurrent