Flecainide Acetate

Product NDC
50090-6810
11-digit product format
500906810
Labeler code
50090
Product ID
50090-6810_f01dc898-446e-4f1c-ad65-f91b98169516
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flecainide Acetate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075442
Marketing category
ANDA
Marketing start
2009-12-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Flecainide Acetate
Listing expiration
2027-12-31

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
50090-6810-0Flecainide Acetate60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6810-0EA - Each50090-68100ae28167-c1e2-4bbd-80c7-291db583065a12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6810FLECAINIDE ACETATE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20231115_166aa9e4-3402-4ebd-baa5-07a8da8aae56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886662flecainide acetate 50 MG Oral TabletPSN166aa9e4-3402-4ebd-baa5-07a8da8aae563
886662flecainide acetate 50 MG Oral TabletSCD166aa9e4-3402-4ebd-baa5-07a8da8aae563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6810-05009068100060 TABLET in 1 BOTTLE (50090-6810-0) 60 tablet2023-11-08NoNoHistorical