Flecainide Acetate

Product NDC
51407-019
11-digit product format
514070019
Labeler code
51407
Product ID
51407-019_3e665020-7874-2ae3-e063-6394a90ac9c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flecainide Acetate Tablet
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075882
Marketing category
ANDA
Marketing start
2002-10-28
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
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
51407-019-01Flecainide Acetate100 in 1 BOTTLETABLET10010
51407-019-60Flecainide Acetate60 in 1 BOTTLETABLET6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-019-01EA - Each51407-019995b8974-12b9-41d4-a762-0596d5d1481a12018-10-11
51407-019-60EA - Each51407-019ade11536-b645-4034-9b93-bc0729a1894e12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-019FLECAINIDE ACETATE (FLECAINIDE ACETATE TABLET) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]9Current NDC, Legacy NDC, 2 package rows20230912_74355cd2-b50e-0dc2-e053-2a91aa0aa164.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886666flecainide acetate 100 MG Oral TabletPSN74355cd2-b50e-0dc2-e053-2a91aa0aa16410
886671flecainide acetate 150 MG Oral TabletPSN74355cd2-b50e-0dc2-e053-2a91aa0aa16410
886662flecainide acetate 50 MG Oral TabletPSN74355cd2-b50e-0dc2-e053-2a91aa0aa16410
886666flecainide acetate 100 MG Oral TabletSCD74355cd2-b50e-0dc2-e053-2a91aa0aa16410
886671flecainide acetate 150 MG Oral TabletSCD74355cd2-b50e-0dc2-e053-2a91aa0aa16410
886662flecainide acetate 50 MG Oral TabletSCD74355cd2-b50e-0dc2-e053-2a91aa0aa16410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-019-0151407001901100 TABLET in 1 BOTTLE (51407-019-01) 100 tablet2018-01-010000-00-00NoNoCurrent
51407-019-605140700196060 TABLET in 1 BOTTLE (51407-019-60) 60 tablet2018-01-010000-00-00NoNoCurrent