Flecainide Acetate

Product NDC
72162-1760
11-digit product format
721621760
Labeler code
72162
Product ID
72162-1760_d3d69961-0cb7-4439-acdf-99bec2148aac
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
72162-1760-172162176001100 TABLET in 1 BOTTLE (72162-1760-1) 100 tablet2023-08-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Flecainide Acetate Tablets USP Rx onlyBryant Ranch Prepack2025-11-03HUMAN PRESCRIPTION DRUG LABEL101
Flecainide Acetate Tablets USP Rx onlyBryant Ranch Prepack2023-08-30HUMAN PRESCRIPTION DRUG LABEL100