Flecainide Acetate

Product NDC
50268-322
11-digit product format
502680322
Labeler code
50268
Product ID
50268-322_742f6e57-6fc0-60ca-e053-2991aa0acca1
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
Marketing end
0000-00-00
Substance
FLECAINIDE ACETATE
Active strength
150 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
50268-322-11Flecainide Acetate1 in 1 BLISTER PACKTABLET19
50268-322-15Flecainide Acetate50 in 1 BOX, UNIT-DOSETABLET509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-322-11EA - Each50268-3226e6f984f-c92c-49a3-97d1-7eefb2e662f812015-06-09
50268-322-15EA - Each50268-322c96866be-c5fc-4f8f-83a2-7189c35ebaf712015-06-09

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
50268-322FLECAINIDE ACETATE TABLET [AVPAK]7Legacy 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 formatDescriptionStatus
50268-322-11502680322111 in 1 BLISTER PACKHistorical
50268-322-155026803221550 in 1 BOX, UNIT-DOSEHistorical