FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
63629-7982
11-digit product format
636297982
Labeler code
63629
Product ID
63629-7982_1a02594a-dc61-44e8-939f-41786366f079
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
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
63629-7982-1Flecainide Acetate30 in 1 BOTTLETABLET305
63629-7982-2Flecainide Acetate60 in 1 BOTTLETABLET605
63629-7982-3Flecainide Acetate90 in 1 BOTTLETABLET905
63629-7982-4Flecainide Acetate180 in 1 BOTTLETABLET1805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7982-3EA - Each63629-7982ef261638-6ef9-443a-ac72-f190f02759a812025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7982FLECAINIDE ACETATE TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 4 package rows20240502_2013e6ef-9141-42c3-8ea8-285840ecdd15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886666flecainide acetate 100 MG Oral TabletPSN2013e6ef-9141-42c3-8ea8-285840ecdd155
886666flecainide acetate 100 MG Oral TabletSCD2013e6ef-9141-42c3-8ea8-285840ecdd155

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7982-16362979820130 TABLET in 1 BOTTLE (63629-7982-1) 30 tablet2019-04-020000-00-00NoNoCurrent
63629-7982-26362979820260 TABLET in 1 BOTTLE (63629-7982-2) 60 tablet2019-05-070000-00-00NoNoCurrent
63629-7982-36362979820390 TABLET in 1 BOTTLE (63629-7982-3) 90 tablet2021-10-060000-00-00NoNoCurrent
63629-7982-463629798204180 TABLET in 1 BOTTLE (63629-7982-4) 180 tablet2024-04-03NoNoCurrent