Flecainide Acetate

Product NDC
63629-9184
11-digit product format
636299184
Labeler code
63629
Product ID
63629-9184_90b6ca54-dac4-43e7-b75e-dbee6370c2f8
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
50 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
M8U465Q1WQFLECAINIDE ACETATE54143-56-5FLECAINIDE ACETATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-9184-163629918401100 TABLET in 1 BOTTLE (63629-9184-1) 100 tablet2022-08-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Flecainide Acetate Tablets USP Rx onlyBryant Ranch Prepack2025-09-10HUMAN PRESCRIPTION DRUG LABEL103