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

Additional Listing Data#

Finished product
Yes
Brand name base
Flecainide Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLECAINIDE ACETATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM8U465Q1WQ
Rxcui886662

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
47936aaf-dd8f-a65f-335e-74a6c45bbd64Product name520231128

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-155-30Flecainide Acetate30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-155-30EA - Each82804-15533f96559-7264-4e5b-a120-8fa06c9dabfc12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-155FLECAINIDE ACETATE (FLECAINIDE ACETATE TABLET) TABLET [PROFICIENT RX LP]1Current NDC, 1 package rows20241010_ee590951-cce8-4a1e-b3bd-ae0b610ebda9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886662flecainide acetate 50 MG Oral TabletPSNee590951-cce8-4a1e-b3bd-ae0b610ebda91
886662flecainide acetate 50 MG Oral TabletSCDee590951-cce8-4a1e-b3bd-ae0b610ebda91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-155-308280401553030 TABLET in 1 BOTTLE (82804-155-30) 30 tablet2024-10-03NoNoCurrent