Flecainide Acetate

Product NDC
50090-2968
11-digit product format
500902968
Labeler code
50090
Product ID
50090-2968_77dd2073-3743-4fbc-9f9b-217d1d788b63
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2968-02023-02-07C16284748780-1f386c64a-3711-0266-e053-dadaa90a7c1aFlecainide Acetate Tablets USP Rx only
50090-2968-02023-01-30C16284748780-1f386c64a-3711-0266-e053-dadaa90a7c1aFlecainide Acetate Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2968-0Flecainide Acetate60 in 1 BOTTLETABLET6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2968-0EA - Each50090-296853ff024e-07c7-4fae-9bd3-4d1c0d2d431212019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2968FLECAINIDE ACETATE TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 1 package rows20230208_1a2a5e08-2697-4a00-94fe-de07148acbd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886666flecainide acetate 100 MG Oral TabletPSN1a2a5e08-2697-4a00-94fe-de07148acbd911
886666flecainide acetate 100 MG Oral TabletSCD1a2a5e08-2697-4a00-94fe-de07148acbd911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2968-05009029680060 TABLET in 1 BOTTLE (50090-2968-0) 60 tablet2017-04-070000-00-00NoNoCurrent