Flecainide Acetate

Product NDC
72789-385
11-digit product format
727890385
Labeler code
72789
Product ID
72789-385_4bc04d15-e3ce-d29c-e063-6294a90a0103
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
50 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
72789-385-0172789038501100 TABLET in 1 BOTTLE, PLASTIC (72789-385-01) 100 tablet2024-02-27NoNoHistorical
72789-385-607278903856060 TABLET in 1 BOTTLE, PLASTIC (72789-385-60) 60 tablet2024-02-27NoNoHistorical
72789-385-9372789038593180 TABLET in 1 BOTTLE, PLASTIC (72789-385-93) 180 tablet2024-02-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Flecainide Acetate Tablets USPPD-Rx Pharmaceuticals, Inc.2026-02-26HUMAN PRESCRIPTION DRUG LABEL7
Flecainide Acetate Tablets USPPD-Rx Pharmaceuticals, Inc.2024-12-03HUMAN PRESCRIPTION DRUG LABEL5