Flecainide Acetate

Product NDC
63629-9184
11-digit product format
636299184
Labeler code
63629
Product ID
63629-9184_90b6ca54-dac4-43e7-b75e-dbee6370c2f8
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
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
63629-9184-1Flecainide Acetate100 in 1 BOTTLETABLET100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9184-1EA - Each63629-9184b9c4d1a0-9f7f-4c9e-a139-b5c96acad93e12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9184FLECAINIDE ACETATE (FLECAINIDE ACETATE TABLET) TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240113_9929c166-8ba3-4159-a5f9-4618d5d227b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886662flecainide acetate 50 MG Oral TabletPSN9929c166-8ba3-4159-a5f9-4618d5d227b0103
886662flecainide acetate 50 MG Oral TabletSCD9929c166-8ba3-4159-a5f9-4618d5d227b0103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9184-163629918401100 TABLET in 1 BOTTLE (63629-9184-1) 100 tablet2022-08-030000-00-00NoNoCurrent