Flecainide Acetate

Product NDC
57237-065
11-digit product format
572370065
Labeler code
57237
Product ID
57237-065_c6b596c3-30c8-4bf6-89f6-03026358a3c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flecainide Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA202821
Marketing category
ANDA
Marketing start
2015-07-08
Substance
FLECAINIDE ACETATE
Active strength
150 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 ACETATE150 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
57237-065-01Flecainide Acetate100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-065-01EA - Each57237-065aba1beca-5696-43c2-9105-20156d6ca1a812015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLECAINIDE ACETATEACTIVE INGREDIENTM8U465Q1WQFLECAINIDE ACETATE TABLET [CITRON PHARMA LLC]1
FLECAINIDEACTIVE MOIETYK94FTS1806FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLECAINIDE ACETATE TABLET [CITRON PHARMA LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC]1
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAFLECAINIDE ACETATE TABLET [CITRON PHARMA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLECAINIDE ACETATE TABLET [CITRON PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-065FLECAINIDE ACETATE TABLET [RISING PHARMA HOLDINGS, INC.]6Current NDC, Legacy NDC, 1 package rows20240113_e56335c1-5508-4136-bd2e-18385623e497.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886671flecainide acetate 150 MG Oral TabletPSN6b73e32f-851b-4503-8296-e5db3a584b75102
886671flecainide acetate 150 MG Oral TabletSCD6b73e32f-851b-4503-8296-e5db3a584b75102
886666flecainide acetate 100 MG Oral TabletPSNe56335c1-5508-4136-bd2e-18385623e4976
886671flecainide acetate 150 MG Oral TabletPSNe56335c1-5508-4136-bd2e-18385623e4976
886662flecainide acetate 50 MG Oral TabletPSNe56335c1-5508-4136-bd2e-18385623e4976
886666flecainide acetate 100 MG Oral TabletSCDe56335c1-5508-4136-bd2e-18385623e4976
886671flecainide acetate 150 MG Oral TabletSCDe56335c1-5508-4136-bd2e-18385623e4976
886662flecainide acetate 50 MG Oral TabletSCDe56335c1-5508-4136-bd2e-18385623e4976

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-065-0157237006501100 TABLET in 1 BOTTLE (57237-065-01) 100 tablet2015-07-080000-00-00NoNoCurrent