FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
0054-0012
11-digit product format
000540012
Labeler code
0054
Product ID
0054-0012_e34a6adf-8794-426e-9e43-11060803a90d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flecainide acetate
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA076278
Marketing category
ANDA
Marketing start
2003-01-14
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
0054-0012-20Flecainide Acetate100 in 1 CARTONTABLET10011
0054-0012-20Flecainide Acetate1 in 1 BLISTER PACKTABLET111
0054-0012-21Flecainide Acetate60 in 1 BOTTLETABLET6011
0054-0012-25Flecainide Acetate100 in 1 BOTTLETABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0012-20EA - Each0054-001220735a67-3b52-44be-8f70-739438821f0212015-05-05
0054-0012-21EA - Each0054-0012a48f1d2c-d968-402f-a5dd-01684880d71512012-07-24
0054-0012-25EA - Each0054-00128de14cdb-5558-486c-9324-8eb71c6c52a812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLECAINIDE ACETATEACTIVE INGREDIENTM8U465Q1WQFLECAINIDE ACETATE TABLET [ROXANE LABORATORIES, INC.]8
FLECAINIDEACTIVE MOIETYK94FTS1806FLECAINIDE ACETATE TABLET [ROXANE LABORATORIES, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLECAINIDE ACETATE TABLET [ROXANE LABORATORIES, INC.]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLECAINIDE ACETATE TABLET [ROXANE LABORATORIES, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLECAINIDE ACETATE TABLET [ROXANE LABORATORIES, INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLECAINIDE ACETATE TABLET [ROXANE LABORATORIES, INC.]8
FLECAINIDE ACETATEACTIVE INGREDIENTM8U465Q1WQFLECAINIDE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
FLECAINIDEACTIVE MOIETYK94FTS1806FLECAINIDE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLECAINIDE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
COTTONSEED OILINACTIVE INGREDIENTH3E878020NFLECAINIDE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLECAINIDE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLECAINIDE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLECAINIDE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0012FLECAINIDE ACETATE TABLET [HIKMA PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 4 package rows20241206_4f6b78d4-8ac8-464b-bb78-ee70cbc97898.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886666flecainide acetate 100 MG Oral TabletPSN4f6b78d4-8ac8-464b-bb78-ee70cbc9789811
886671flecainide acetate 150 MG Oral TabletPSN4f6b78d4-8ac8-464b-bb78-ee70cbc9789811
886662flecainide acetate 50 MG Oral TabletPSN4f6b78d4-8ac8-464b-bb78-ee70cbc9789811
886666flecainide acetate 100 MG Oral TabletSCD4f6b78d4-8ac8-464b-bb78-ee70cbc9789811
886671flecainide acetate 150 MG Oral TabletSCD4f6b78d4-8ac8-464b-bb78-ee70cbc9789811
886662flecainide acetate 50 MG Oral TabletSCD4f6b78d4-8ac8-464b-bb78-ee70cbc9789811
886666flecainide acetate 100 MG Oral TabletPSN89105dbf-1085-4c81-ab19-49c7b5966e7d2
886671flecainide acetate 150 MG Oral TabletPSN89105dbf-1085-4c81-ab19-49c7b5966e7d2
886662flecainide acetate 50 MG Oral TabletPSN89105dbf-1085-4c81-ab19-49c7b5966e7d2
886666flecainide acetate 100 MG Oral TabletSCD89105dbf-1085-4c81-ab19-49c7b5966e7d2
886671flecainide acetate 150 MG Oral TabletSCD89105dbf-1085-4c81-ab19-49c7b5966e7d2
886662flecainide acetate 50 MG Oral TabletSCD89105dbf-1085-4c81-ab19-49c7b5966e7d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0012-2000054001220100 BLISTER PACK in 1 CARTON (0054-0012-20) / 1 TABLET in 1 BLISTER PACK100 blister pack2003-01-140000-00-00NoNoCurrent
0054-0012-210005400122160 TABLET in 1 BOTTLE (0054-0012-21) 60 tablet2003-01-140000-00-00NoNoCurrent
0054-0012-2500054001225100 TABLET in 1 BOTTLE (0054-0012-25) 100 tablet2003-01-140000-00-00NoNoCurrent