FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
50268-321
11-digit product format
502680321
Labeler code
50268
Product ID
50268-321_48253893-9512-565b-e063-6294a90a8ad8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flecainide Acetate
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA075442
Marketing category
ANDA
Marketing start
2015-02-12
Substance
FLECAINIDE ACETATE
Active strength
100 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 ACETATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM8U465Q1WQ
Rxcui886662, 886666, 886671

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
50268-321-11Flecainide Acetate1 in 1 BLISTER PACKTABLET19
50268-321-15Flecainide Acetate50 in 1 BOX, UNIT-DOSETABLET509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-321-11EA - Each50268-32166be8525-f48a-4903-b522-784d6d74fc7412015-06-09
50268-321-15EA - Each50268-321831a91fe-df32-4104-89c4-5a89e2ba66a012015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLECAINIDE ACETATEACTIVE INGREDIENTM8U465Q1WQFLECAINIDE ACETATE TABLET [AVPAK]1
FLECAINIDEACTIVE MOIETYK94FTS1806FLECAINIDE ACETATE TABLET [AVPAK]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UFLECAINIDE ACETATE TABLET [AVPAK]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48FLECAINIDE ACETATE TABLET [AVPAK]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30FLECAINIDE ACETATE TABLET [AVPAK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-321FLECAINIDE ACETATE TABLET [AVPAK]7Current NDC, Legacy NDC, 2 package rows20240110_f53e1a49-6185-6db4-c867-ffd1241a8cb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886666flecainide acetate 100 MG Oral TabletPSNf53e1a49-6185-6db4-c867-ffd1241a8cb79
886671flecainide acetate 150 MG Oral TabletPSNf53e1a49-6185-6db4-c867-ffd1241a8cb79
886662flecainide acetate 50 MG Oral TabletPSNf53e1a49-6185-6db4-c867-ffd1241a8cb79
886666flecainide acetate 100 MG Oral TabletSCDf53e1a49-6185-6db4-c867-ffd1241a8cb79
886671flecainide acetate 150 MG Oral TabletSCDf53e1a49-6185-6db4-c867-ffd1241a8cb79
886662flecainide acetate 50 MG Oral TabletSCDf53e1a49-6185-6db4-c867-ffd1241a8cb79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-321-11502680321111 in 1 BLISTER PACKHistorical
50268-321-155026803211550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-321-15) / 1 TABLET in 1 BLISTER PACK (50268-321-11) 50 blister pack2015-02-120000-00-00NoNoCurrent