Flecainide Acetate

Product NDC
50090-6035
11-digit product format
500906035
Labeler code
50090
Product ID
50090-6035_78ac1148-3977-4e81-a57f-d09c59a41267
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flecainide Acetate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-6035-0Flecainide Acetate60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6035-0EA - Each50090-603599ecaf3d-5303-4258-82ea-2d4a52ef794112022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6035FLECAINIDE ACETATE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20231202_179e3821-0342-4b84-96bb-3fcab213d74f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886662flecainide acetate 50 MG Oral TabletPSN179e3821-0342-4b84-96bb-3fcab213d74f3
886662flecainide acetate 50 MG Oral TabletSCD179e3821-0342-4b84-96bb-3fcab213d74f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6035-05009060350060 TABLET in 1 BOTTLE (50090-6035-0) 60 tablet2022-07-120000-00-00NoNoCurrent