Flecainide Acetate

Product NDC
63629-1945
11-digit product format
636291945
Labeler code
63629
Product ID
63629-1945_53e01a4a-d6ee-4f76-94ce-40fbede5eeae
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
100 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 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
63629-1945-1Flecainide Acetate100 in 1 BOTTLETABLET100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1945-1EA - Each63629-194575d023f0-71af-4f39-9cff-a0538fb9395a12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1945FLECAINIDE ACETATE (FLECAINIDE ACETATE TABLET) TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240608_8dc86db1-2a09-4625-80eb-ff6ce9de2d7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886666flecainide acetate 100 MG Oral TabletPSN8dc86db1-2a09-4625-80eb-ff6ce9de2d7a104
886666flecainide acetate 100 MG Oral TabletSCD8dc86db1-2a09-4625-80eb-ff6ce9de2d7a104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1945-163629194501100 TABLET in 1 BOTTLE (63629-1945-1) 100 tablet2021-01-140000-00-00NoNoCurrent