Flecainide Acetate

Product NDC
72162-1761
11-digit product format
721621761
Labeler code
72162
Product ID
72162-1761_d7ef3cfb-c310-4d8b-b8a6-bdf4dedfd642
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1761-172162176101100 TABLET in 1 BOTTLE (72162-1761-1) 100 tablet2023-10-04NoNoHistorical

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 Prepack2023-10-04HUMAN PRESCRIPTION DRUG LABEL100