FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
72789-384
11-digit product format
727890384
Labeler code
72789
Product ID
72789-384_4bc0523c-158e-9ad2-e063-6294a90a5b87
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
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
Rxcui886671

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
72789-384-01Flecainide Acetate100 in 1 BOTTLE, PLASTICTABLET1004
72789-384-60Flecainide Acetate60 in 1 BOTTLE, PLASTICTABLET604
72789-384-93Flecainide Acetate180 in 1 BOTTLE, PLASTICTABLET1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-384-01EA - Each72789-38435752ea2-1648-4cb5-9e50-f4a8e19db78d12024-04-05
72789-384-60EA - Each72789-384c8049304-0757-4f00-96a5-9a5e66dcbea412024-04-05
72789-384-93EA - Each72789-384d633fb3d-978b-4c9e-8e0a-1ce9a542cd7112024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-384FLECAINIDE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2Current NDC, 3 package rows20240307_45d39dff-22d9-4c04-af26-0cffd41abaa8.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-384-0172789038401100 TABLET in 1 BOTTLE, PLASTIC (72789-384-01) 100 tablet2024-03-05NoNoCurrent
72789-384-607278903846060 TABLET in 1 BOTTLE, PLASTIC (72789-384-60) 60 tablet2024-03-05NoNoCurrent
72789-384-9372789038493180 TABLET in 1 BOTTLE, PLASTIC (72789-384-93) 180 tablet2024-03-05NoNoCurrent