FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
76385-146
11-digit product format
763850146
Labeler code
76385
Product ID
76385-146_6e5f6cbe-c7eb-4168-b02b-119798e895d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flecainide acetate
Dosage form
TABLET
Route
ORAL
Labeler
UNICHEM PHARMACEUTICALS (USA), INC.
Application
ANDA210683
Marketing category
ANDA
Marketing start
2024-01-11
Substance
FLECAINIDE ACETATE
Active strength
100 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Flecainide Acetate
Listing expiration
2027-12-31

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
76385-146-01Flecainide Acetate100 in 1 BOTTLETABLET1002
76385-146-60Flecainide Acetate60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76385-146FLECAINIDE ACETATE TABLET [BAYSHORE PHARMACEUTICALS LLC]1Current NDC, 2 package rows20240112_5b33e96a-8336-46c4-aac7-4a6c0039cc80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886666flecainide acetate 100 MG Oral TabletPSNabcb261b-30ae-4eb1-baf0-e9667a2bd8cf8
886666flecainide acetate 100 MG Oral TabletSCDabcb261b-30ae-4eb1-baf0-e9667a2bd8cf8
886666flecainide acetate 100 MG Oral TabletPSN5b33e96a-8336-46c4-aac7-4a6c0039cc802
886666flecainide acetate 100 MG Oral TabletPSNa30103c5-a261-49a5-a7b3-f43eb77e87b72
886671flecainide acetate 150 MG Oral TabletPSN5b33e96a-8336-46c4-aac7-4a6c0039cc802
886662flecainide acetate 50 MG Oral TabletPSN5b33e96a-8336-46c4-aac7-4a6c0039cc802
886666flecainide acetate 100 MG Oral TabletSCD5b33e96a-8336-46c4-aac7-4a6c0039cc802
886666flecainide acetate 100 MG Oral TabletSCDa30103c5-a261-49a5-a7b3-f43eb77e87b72
886671flecainide acetate 150 MG Oral TabletSCD5b33e96a-8336-46c4-aac7-4a6c0039cc802
886662flecainide acetate 50 MG Oral TabletSCD5b33e96a-8336-46c4-aac7-4a6c0039cc802

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76385-146-0176385014601100 TABLET in 1 BOTTLE (76385-146-01) 100 tablet2024-01-11NoNoCurrent
76385-146-607638501466060 TABLET in 1 BOTTLE (76385-146-60) 60 tablet2024-01-11NoNoCurrent