Flecainide Acetate

Product NDC
50090-5306
11-digit product format
500905306
Labeler code
50090
Product ID
50090-5306_c97a62d4-b357-486d-a0be-6a87af13f749
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flecainide Acetate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202821
Marketing category
ANDA
Marketing start
2015-07-08
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5306-02023-02-06C16284748780-1f386c649-b435-0266-e053-dadaa90a7c1aFlecainide Acetate Tablets, USP Rx only
50090-5306-02023-01-30C16284748780-1f386c649-b435-0266-e053-dadaa90a7c1aFlecainide Acetate Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5306-0Flecainide Acetate60 in 1 BOTTLETABLET607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5306-0EA - Each50090-5306ed9bbdbb-5a05-490b-b6b0-915df9167af512025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5306FLECAINIDE ACETATE TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 1 package rows20241115_475a52a9-f18c-4a69-91f0-8f5e601f4336.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886662flecainide acetate 50 MG Oral TabletPSN475a52a9-f18c-4a69-91f0-8f5e601f43367
886662flecainide acetate 50 MG Oral TabletSCD475a52a9-f18c-4a69-91f0-8f5e601f43367

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5306-05009053060060 TABLET in 1 BOTTLE (50090-5306-0) 60 tablet2020-10-280000-00-00NoNoCurrent