Flecainide Acetate

Product NDC
72789-384
11-digit product format
727890384
Labeler code
72789
Product ID
72789-384_4bc0523c-158e-9ad2-e063-6294a90a5b87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flecainide acetate
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA210683
Marketing category
ANDA
Marketing start
2024-01-11
Substance
FLECAINIDE ACETATE
Active strength
150 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
72789-384-0172789038401100 TABLET in 1 BOTTLE, PLASTIC (72789-384-01) 100 tablet2024-03-05NoNoHistorical
72789-384-607278903846060 TABLET in 1 BOTTLE, PLASTIC (72789-384-60) 60 tablet2024-03-05NoNoHistorical
72789-384-9372789038493180 TABLET in 1 BOTTLE, PLASTIC (72789-384-93) 180 tablet2024-03-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Flecainide Acetate Tablets USPPD-Rx Pharmaceuticals, Inc.2026-02-26HUMAN PRESCRIPTION DRUG LABEL4