FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
53746-641
11-digit product format
537460641
Labeler code
53746
Product ID
53746-641_fe4cd965-0740-40bc-a301-26e337c8406e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flecainide Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA075442
Marketing category
ANDA
Marketing start
2009-12-01
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, 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
53746-641-01Flecainide Acetate100 in 1 BOTTLETABLET1009
53746-641-10Flecainide Acetate1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-641-01EA - Each53746-641a0c25c94-576c-4c39-85c8-cf152855b4aa12018-02-20

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
53746-641FLECAINIDE ACETATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]9Current NDC, Legacy NDC, 2 package rows20240101_ee9595d5-08a1-4529-9215-ddc3c7f929c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886666flecainide acetate 100 MG Oral TabletPSNee9595d5-08a1-4529-9215-ddc3c7f929c49
886666flecainide acetate 100 MG Oral TabletPSNf53e1a49-6185-6db4-c867-ffd1241a8cb79
886671flecainide acetate 150 MG Oral TabletPSNee9595d5-08a1-4529-9215-ddc3c7f929c49
886671flecainide acetate 150 MG Oral TabletPSNf53e1a49-6185-6db4-c867-ffd1241a8cb79
886662flecainide acetate 50 MG Oral TabletPSNee9595d5-08a1-4529-9215-ddc3c7f929c49
886662flecainide acetate 50 MG Oral TabletPSNf53e1a49-6185-6db4-c867-ffd1241a8cb79
886666flecainide acetate 100 MG Oral TabletSCDee9595d5-08a1-4529-9215-ddc3c7f929c49
886666flecainide acetate 100 MG Oral TabletSCDf53e1a49-6185-6db4-c867-ffd1241a8cb79
886671flecainide acetate 150 MG Oral TabletSCDee9595d5-08a1-4529-9215-ddc3c7f929c49
886671flecainide acetate 150 MG Oral TabletSCDf53e1a49-6185-6db4-c867-ffd1241a8cb79
886662flecainide acetate 50 MG Oral TabletSCDee9595d5-08a1-4529-9215-ddc3c7f929c49
886662flecainide acetate 50 MG Oral TabletSCDf53e1a49-6185-6db4-c867-ffd1241a8cb79
886662flecainide acetate 50 MG Oral TabletPSN166aa9e4-3402-4ebd-baa5-07a8da8aae563
886662flecainide acetate 50 MG Oral TabletSCD166aa9e4-3402-4ebd-baa5-07a8da8aae563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-641-0153746064101100 TABLET in 1 BOTTLE (53746-641-01) 100 tablet2009-12-010000-00-00NoNoCurrent
53746-641-10537460641101000 TABLET in 1 BOTTLE (53746-641-10) 1000 tablet2009-12-010000-00-00NoNoCurrent