FDA.reportPublic FDA data

Flecainide Acetate

Product NDC
50090-2233
Requested package NDC
50090-2233-0
11-digit product format
500902233
Labeler code
50090
Product ID
50090-2233_d64099b1-9879-4d9f-b325-f23d16d120dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flecainide Acetate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202821
Marketing category
ANDA
Marketing start
2017-11-03
Marketing end
0000-00-00
Substance
FLECAINIDE ACETATE
Active strength
100 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-223350090-2233-0IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202821-001FLECAINIDE ACETATEFLECAINIDE ACETATE50MGTABLET / ORALAB2017-11-03
A202821-002FLECAINIDE ACETATEFLECAINIDE ACETATE100MGTABLET / ORALAB2017-11-03
A202821-003FLECAINIDE ACETATEFLECAINIDE ACETATE150MGTABLET / ORALAB2017-11-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202821-001AB
A202821-002AB
A202821-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202821-001FLECAINIDE ACETATE50MGTABLET / ORALAB2017-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202821-002FLECAINIDE ACETATE100MGTABLET / ORALAB2017-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202821-003FLECAINIDE ACETATE150MGTABLET / ORALAB2017-11-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202821-001FLECAINIDE ACETATE50MGTABLET / ORALAB2017-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202821-002FLECAINIDE ACETATE100MGTABLET / ORALAB2017-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202821-003FLECAINIDE ACETATE150MGTABLET / ORALAB2017-11-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A202821-001FLECAINIDE ACETATE50MGTABLET / ORALAB2017-11-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202821-002FLECAINIDE ACETATE100MGTABLET / ORALAB2017-11-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202821-003FLECAINIDE ACETATE150MGTABLET / ORALAB2017-11-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202821-001FLECAINIDE ACETATE50MGTABLET / ORALAB2017-11-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202821-002FLECAINIDE ACETATE100MGTABLET / ORALAB2017-11-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202821-003FLECAINIDE ACETATE150MGTABLET / ORALAB2017-11-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202821-001FLECAINIDE ACETATE50MGTABLET / ORALAB2017-11-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202821-002FLECAINIDE ACETATE100MGTABLET / ORALAB2017-11-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202821-003FLECAINIDE ACETATE150MGTABLET / ORALAB2017-11-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202821-001FLECAINIDE ACETATE50MGTABLET / ORALAB2017-11-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202821-002FLECAINIDE ACETATE100MGTABLET / ORALAB2017-11-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202821-003FLECAINIDE ACETATE150MGTABLET / ORALAB2017-11-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202821-001FLECAINIDE ACETATE50MGTABLET / ORALAB2017-11-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202821-002FLECAINIDE ACETATE100MGTABLET / ORALAB2017-11-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202821-003FLECAINIDE ACETATE150MGTABLET / ORALAB2017-11-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202821-001FLECAINIDE ACETATE50MGTABLET / ORALAB2017-11-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202821-002FLECAINIDE ACETATE100MGTABLET / ORALAB2017-11-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202821-003FLECAINIDE ACETATE150MGTABLET / ORALAB2017-11-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202821-001FLECAINIDE ACETATE50MGTABLET / ORALAB2017-11-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202821-002FLECAINIDE ACETATE100MGTABLET / ORALAB2017-11-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202821-003FLECAINIDE ACETATE150MGTABLET / ORALAB2017-11-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202821-001FLECAINIDE ACETATE50MGTABLET / ORALAB2017-11-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A202821-002FLECAINIDE ACETATE100MGTABLET / ORALAB2017-11-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A202821-003FLECAINIDE ACETATE150MGTABLET / ORALAB2017-11-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202821-001FLECAINIDE ACETATE50MGTABLET / ORALAB2017-11-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202821-002FLECAINIDE ACETATE100MGTABLET / ORALAB2017-11-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202821-003FLECAINIDE ACETATE150MGTABLET / ORALAB2017-11-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202821-001FLECAINIDE ACETATE50MGTABLET / ORALAB2017-11-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202821-002FLECAINIDE ACETATE100MGTABLET / ORALAB2017-11-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202821-003FLECAINIDE ACETATE150MGTABLET / ORALAB2017-11-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202821-001FLECAINIDE ACETATE50MGTABLET / ORALAB2017-11-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202821-002FLECAINIDE ACETATE100MGTABLET / ORALAB2017-11-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202821-003FLECAINIDE ACETATE150MGTABLET / ORALAB2017-11-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202821-001FLECAINIDE ACETATE50MGTABLET / ORALAB2017-11-038072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202821-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202821-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202821-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202821-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202821-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202821-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202821-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202821-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202821-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202821-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202821-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202821-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202821-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202821-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202821-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202821-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202821-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202821-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202821-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202821-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202821-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202821-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202821-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202821-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202821-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202821-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202821-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202821-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202821-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202821-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202821-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202821-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202821-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202821-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202821-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202821-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202821-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202821-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202821-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202821-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
47936aaf-dd8f-a65f-335e-74a6c45bbd64Product name520231128

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2233-02023-01-30C16284748780-1f386c649-abbf-0266-e053-dadaa90a7c1aFlecainide Acetate Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2233-0Flecainide Acetate60 in 1 BOTTLETABLET605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2233-0EA - Each50090-2233c073cff4-85c8-4d82-a7a0-4ad50e8760c612021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2233FLECAINIDE ACETATE TABLET [A-S MEDICATION SOLUTIONS]5Legacy NDC, 1 package rows20210227_552ce99a-1195-4f53-971a-ad5874bba9d5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flecainide AcetateFLECAINIDE ACETATEA-S Medication Solutions475a52a9-f18c-4a69-91f0-8f5e601f43362024-11-13Boxed warning, Adverse reactionsExact identifier
application applno (ANDA): 202821
application number: ANDA202821
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack6b73e32f-851b-4503-8296-e5db3a584b752024-05-24Boxed warning, Adverse reactionsExact identifier
application applno (ANDA): 202821
application number: ANDA202821
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack2013e6ef-9141-42c3-8ea8-285840ecdd152024-04-03Boxed warning, Adverse reactionsExact identifier
application applno (ANDA): 202821
application number: ANDA202821
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack5d6a4772-663e-468d-a8e1-4085e1b32bf72024-04-03Boxed warning, Adverse reactionsExact identifier
application applno (ANDA): 202821
application number: ANDA202821
Flecainide AcetateFLECAINIDE ACETATEAurobindo Pharma Limited14e89448-3a18-42e3-8537-2589be1ef94e2024-01-09Boxed warning, Adverse reactionsExact identifier
application applno (ANDA): 202821
application number: ANDA202821
Flecainide AcetateFLECAINIDE ACETATERising Pharma Holdings, Inc.e56335c1-5508-4136-bd2e-18385623e4972024-01-09Boxed warning, Adverse reactionsExact identifier
application applno (ANDA): 202821
application number: ANDA202821

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886666flecainide acetate 100 MG Oral TabletPSN552ce99a-1195-4f53-971a-ad5874bba9d55
886666flecainide acetate 100 MG Oral TabletSCD552ce99a-1195-4f53-971a-ad5874bba9d55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2233-05009022330060 TABLET in 1 BOTTLE (50090-2233-0) 60 tablet2017-11-030000-00-00NoNoCurrent