Flecainide Acetate

Product NDC
50090-7316
11-digit product format
500907316
Labeler code
50090
Product ID
50090-7316_c8e8b229-cc66-4cdf-a320-531ec28560e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flecainide acetate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA215599
Marketing category
ANDA
Marketing start
2022-09-15
Substance
FLECAINIDE ACETATE
Active strength
100 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 ACETATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM8U465Q1WQ
Rxcui886666

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
50090-7316-0Flecainide Acetate60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7316-0EA - Each50090-7316276762e7-6c3d-4be4-b6ed-3db576b035b112024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7316FLECAINIDE ACETATE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20241018_9aa3bd74-d8c3-4e40-a1be-19111492b652.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886666flecainide acetate 100 MG Oral TabletPSN9aa3bd74-d8c3-4e40-a1be-19111492b6521
886666flecainide acetate 100 MG Oral TabletSCD9aa3bd74-d8c3-4e40-a1be-19111492b6521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7316-05009073160060 TABLET in 1 BOTTLE (50090-7316-0) 60 tablet2024-10-14NoNoCurrent