FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
76385-147
11-digit product format
763850147
Labeler code
76385
Product ID
76385-147_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
150 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 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
76385-147-01Flecainide Acetate100 in 1 BOTTLETABLET1002
76385-147-60Flecainide Acetate60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76385-147-01EA - Each76385-147d67c71ed-5a8f-4a08-bf40-c00107a98b7312024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76385-147FLECAINIDE 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
886671flecainide acetate 150 MG Oral TabletPSN45d39dff-22d9-4c04-af26-0cffd41abaa84
886671flecainide acetate 150 MG Oral TabletSCD45d39dff-22d9-4c04-af26-0cffd41abaa84
886666flecainide acetate 100 MG Oral TabletPSN5b33e96a-8336-46c4-aac7-4a6c0039cc802
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
886671flecainide acetate 150 MG Oral TabletSCD5b33e96a-8336-46c4-aac7-4a6c0039cc802
886662flecainide acetate 50 MG Oral TabletSCD5b33e96a-8336-46c4-aac7-4a6c0039cc802
886671flecainide acetate 150 MG Oral TabletPSNbf810a3b-1a71-4a05-bf54-d5a6caba444b1
886671flecainide acetate 150 MG Oral TabletSCDbf810a3b-1a71-4a05-bf54-d5a6caba444b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76385-147-0176385014701100 TABLET in 1 BOTTLE (76385-147-01) 100 tablet2024-01-15NoNoCurrent
76385-147-607638501476060 TABLET in 1 BOTTLE (76385-147-60) 60 tablet2024-01-15NoNoCurrent