FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
72789-383
11-digit product format
727890383
Labeler code
72789
Product ID
72789-383_4bc0370f-21ea-1acb-e063-6394a90ad768
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flecainide acetate
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, 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
Rxcui886666

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
72789-383-01Flecainide Acetate100 in 1 BOTTLE, PLASTICTABLET1008
72789-383-60Flecainide Acetate60 in 1 BOTTLE, PLASTICTABLET608
72789-383-93Flecainide Acetate180 in 1 BOTTLE, PLASTICTABLET1808

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-383-01EA - Each72789-3839737082c-b94e-41ac-b73f-b15341cab80612024-04-05
72789-383-60EA - Each72789-3838a135a4e-249a-4b08-973b-02d8b48ad0f812024-04-05
72789-383-93EA - Each72789-383c96bd694-7ee6-4406-8598-1773103e261a12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-383FLECAINIDE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]6Current NDC, 3 package rows20250131_abcb261b-30ae-4eb1-baf0-e9667a2bd8cf.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-383-0172789038301100 TABLET in 1 BOTTLE, PLASTIC (72789-383-01) 100 tablet2024-02-28NoNoCurrent
72789-383-607278903836060 TABLET in 1 BOTTLE, PLASTIC (72789-383-60) 60 tablet2024-02-27NoNoCurrent
72789-383-9372789038393180 TABLET in 1 BOTTLE, PLASTIC (72789-383-93) 180 tablet2024-02-28NoNoCurrent