Flecainide Acetate

Product NDC
42806-818
11-digit product format
428060818
Labeler code
42806
Product ID
42806-818_44e0bf64-72e3-4168-e063-6294a90a3934
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flecainide acetate
Dosage form
TABLET
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA215599
Marketing category
ANDA
Marketing start
2022-09-15
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
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
42806-818-01Flecainide Acetate100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-818-01EA - Each42806-818330accc2-7b83-41b8-828d-d0bf993679c912023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-818FLECAINIDE ACETATE TABLET [EPIC PHARMA, LLC]5Current NDC, Legacy NDC, 1 package rows20240620_74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886666flecainide acetate 100 MG Oral TabletPSN74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc8
886671flecainide acetate 150 MG Oral TabletPSN74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc8
886662flecainide acetate 50 MG Oral TabletPSN74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc8
886666flecainide acetate 100 MG Oral TabletSCD74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc8
886671flecainide acetate 150 MG Oral TabletSCD74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc8
886662flecainide acetate 50 MG Oral TabletSCD74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc8
886666flecainide acetate 100 MG Oral TabletPSN8a900f29-85e1-464c-ae9e-44dc7cf11f461
886666flecainide acetate 100 MG Oral TabletPSN9aa3bd74-d8c3-4e40-a1be-19111492b6521
886666flecainide acetate 100 MG Oral TabletSCD8a900f29-85e1-464c-ae9e-44dc7cf11f461
886666flecainide acetate 100 MG Oral TabletSCD9aa3bd74-d8c3-4e40-a1be-19111492b6521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-818-0142806081801100 TABLET in 1 BOTTLE (42806-818-01) 100 tablet2022-09-150000-00-00NoNoCurrent