FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
63629-7979
11-digit product format
636297979
Labeler code
63629
Product ID
63629-7979_3d65643b-e585-4e81-8792-9089e0fbabd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flecainide Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202821
Marketing category
ANDA
Marketing start
2015-07-08
Substance
FLECAINIDE ACETATE
Active strength
50 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 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
63629-7979-1Flecainide Acetate30 in 1 BOTTLETABLET30104
63629-7979-2Flecainide Acetate60 in 1 BOTTLETABLET60104
63629-7979-3Flecainide Acetate90 in 1 BOTTLETABLET90104
63629-7979-4Flecainide Acetate10 in 1 BOTTLETABLET10104
63629-7979-5Flecainide Acetate180 in 1 BOTTLETABLET180104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7979-2EA - Each63629-797948d57ef2-1448-4d45-aa20-e11f315b44e612025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7979FLECAINIDE ACETATE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 5 package rows20240502_5d6a4772-663e-468d-a8e1-4085e1b32bf7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886662flecainide acetate 50 MG Oral TabletPSN5d6a4772-663e-468d-a8e1-4085e1b32bf7104
886662flecainide acetate 50 MG Oral TabletSCD5d6a4772-663e-468d-a8e1-4085e1b32bf7104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7979-16362979790130 TABLET in 1 BOTTLE (63629-7979-1) 30 tablet2019-05-090000-00-00NoNoCurrent
63629-7979-26362979790260 TABLET in 1 BOTTLE (63629-7979-2) 60 tablet2019-03-280000-00-00NoNoCurrent
63629-7979-36362979790390 TABLET in 1 BOTTLE (63629-7979-3) 90 tablet2021-01-070000-00-00NoNoCurrent
63629-7979-46362979790410 TABLET in 1 BOTTLE (63629-7979-4) 10 tablet2024-04-030000-00-00NoNoCurrent
63629-7979-563629797905180 TABLET in 1 BOTTLE (63629-7979-5) 180 tablet2022-09-28NoNoCurrent