Flecainide Acetate

Product NDC
82804-155
11-digit product format
828040155
Labeler code
82804
Product ID
82804-155_ee590951-cce8-4a1e-b3bd-ae0b610ebda9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flecainide Acetate Tablet
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
82804-155-308280401553030 TABLET in 1 BOTTLE (82804-155-30) 30 tablet2024-10-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Flecainide Acetate Tablets USP Rx onlyProficient Rx LP2024-10-01HUMAN PRESCRIPTION DRUG LABEL1