FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
72789-385
11-digit product format
727890385
Labeler code
72789
Product ID
72789-385_4bc04d15-e3ce-d29c-e063-6294a90a0103
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
50 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 ACETATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM8U465Q1WQ
Rxcui886662

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
72789-385-01Flecainide Acetate100 in 1 BOTTLE, PLASTICTABLET1007
72789-385-60Flecainide Acetate60 in 1 BOTTLE, PLASTICTABLET607
72789-385-93Flecainide Acetate180 in 1 BOTTLE, PLASTICTABLET1807

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-385-01EA - Each72789-385d12bb8c1-06cf-4ee7-b9e1-1092e46a1d2612024-04-05
72789-385-60EA - Each72789-385f20b5584-458a-41a9-8ea1-0d47c487789212024-04-05
72789-385-93EA - Each72789-3852c998bed-186e-469e-9ff3-106206425fad12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-385FLECAINIDE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]5Current NDC, 3 package rows20241206_2b336028-1e13-4ef7-b75e-345bc9c06f9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886662flecainide acetate 50 MG Oral TabletPSN2b336028-1e13-4ef7-b75e-345bc9c06f9a7
886662flecainide acetate 50 MG Oral TabletSCD2b336028-1e13-4ef7-b75e-345bc9c06f9a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-385-0172789038501100 TABLET in 1 BOTTLE, PLASTIC (72789-385-01) 100 tablet2024-02-27NoNoCurrent
72789-385-607278903856060 TABLET in 1 BOTTLE, PLASTIC (72789-385-60) 60 tablet2024-02-27NoNoCurrent
72789-385-9372789038593180 TABLET in 1 BOTTLE, PLASTIC (72789-385-93) 180 tablet2024-02-27NoNoCurrent