Flecainide Acetate

Product NDC
50090-7316
11-digit product format
500907316
Labeler code
50090
Product ID
50090-7316_c8e8b229-cc66-4cdf-a320-531ec28560e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flecainide acetate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-7316DDiscontinued by firm2026-08-11
excluded packagepackage50090-731650090-7316-0DDiscontinued by firm2026-08-11

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
A215599-001FLECAINIDE ACETATEFLECAINIDE ACETATE50MGTABLET / ORALAB2022-09-08
A215599-002FLECAINIDE ACETATEFLECAINIDE ACETATE100MGTABLET / ORALAB2022-09-08
A215599-003FLECAINIDE ACETATEFLECAINIDE ACETATE150MGTABLET / ORALAB2022-09-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215599-001AB
A215599-002AB
A215599-003AB

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 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215599-001FLECAINIDE ACETATE50MGTABLET / ORALAB2022-09-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215599-002FLECAINIDE ACETATE100MGTABLET / ORALAB2022-09-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215599-003FLECAINIDE ACETATE150MGTABLET / ORALAB2022-09-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215599-001FLECAINIDE ACETATE50MGTABLET / ORALAB2022-09-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215599-002FLECAINIDE ACETATE100MGTABLET / ORALAB2022-09-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215599-003FLECAINIDE ACETATE150MGTABLET / ORALAB2022-09-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A215599-001FLECAINIDE ACETATE50MGTABLET / ORALAB2022-09-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215599-002FLECAINIDE ACETATE100MGTABLET / ORALAB2022-09-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215599-003FLECAINIDE ACETATE150MGTABLET / ORALAB2022-09-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215599-001FLECAINIDE ACETATE50MGTABLET / ORALAB2022-09-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215599-002FLECAINIDE ACETATE100MGTABLET / ORALAB2022-09-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215599-003FLECAINIDE ACETATE150MGTABLET / ORALAB2022-09-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215599-001FLECAINIDE ACETATE50MGTABLET / ORALAB2022-09-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215599-002FLECAINIDE ACETATE100MGTABLET / ORALAB2022-09-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215599-003FLECAINIDE ACETATE150MGTABLET / ORALAB2022-09-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215599-001FLECAINIDE ACETATE50MGTABLET / ORALAB2022-09-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215599-002FLECAINIDE ACETATE100MGTABLET / ORALAB2022-09-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215599-003FLECAINIDE ACETATE150MGTABLET / ORALAB2022-09-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215599-001FLECAINIDE ACETATE50MGTABLET / ORALAB2022-09-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215599-002FLECAINIDE ACETATE100MGTABLET / ORALAB2022-09-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215599-003FLECAINIDE ACETATE150MGTABLET / ORALAB2022-09-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215599-001FLECAINIDE ACETATE50MGTABLET / ORALAB2022-09-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215599-002FLECAINIDE ACETATE100MGTABLET / ORALAB2022-09-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215599-003FLECAINIDE ACETATE150MGTABLET / ORALAB2022-09-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215599-001FLECAINIDE ACETATE50MGTABLET / ORALAB2022-09-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215599-002FLECAINIDE ACETATE100MGTABLET / ORALAB2022-09-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215599-003FLECAINIDE ACETATE150MGTABLET / ORALAB2022-09-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215599-001FLECAINIDE ACETATE50MGTABLET / ORALAB2022-09-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A215599-002FLECAINIDE ACETATE100MGTABLET / ORALAB2022-09-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A215599-003FLECAINIDE ACETATE150MGTABLET / ORALAB2022-09-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215599-001FLECAINIDE ACETATE50MGTABLET / ORALAB2022-09-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215599-002FLECAINIDE ACETATE100MGTABLET / ORALAB2022-09-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215599-003FLECAINIDE ACETATE150MGTABLET / ORALAB2022-09-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215599-001FLECAINIDE ACETATE50MGTABLET / ORALAB2022-09-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215599-002FLECAINIDE ACETATE100MGTABLET / ORALAB2022-09-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215599-003FLECAINIDE ACETATE150MGTABLET / ORALAB2022-09-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215599-001FLECAINIDE ACETATE50MGTABLET / ORALAB2022-09-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215599-002FLECAINIDE ACETATE100MGTABLET / ORALAB2022-09-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215599-003FLECAINIDE ACETATE150MGTABLET / ORALAB2022-09-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215599-001FLECAINIDE ACETATE50MGTABLET / ORALAB2022-09-088072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215599-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215599-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215599-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215599-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215599-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215599-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215599-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215599-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215599-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215599-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215599-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215599-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215599-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215599-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215599-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215599-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215599-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215599-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215599-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215599-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215599-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215599-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215599-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215599-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215599-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215599-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215599-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215599-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215599-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215599-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215599-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215599-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215599-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215599-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215599-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215599-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215599-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215599-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215599-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215599-001AB18072bd15b7f6…

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
50090-7316-0Flecainide Acetate60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7316-0EA - Each50090-7316276762e7-6c3d-4be4-b6ed-3db576b035b112024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7316FLECAINIDE ACETATE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20241018_9aa3bd74-d8c3-4e40-a1be-19111492b652.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flecainide AcetateFLECAINIDE ACETATEEpic Pharma, LLC74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215599
application number: ANDA215599
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack8a900f29-85e1-464c-ae9e-44dc7cf11f462026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215599
application number: ANDA215599
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack5cfa10ba-dfe8-42ab-81b3-8cca657aba072026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215599
application number: ANDA215599
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepackb821ec16-93ff-4569-9fbb-4f3842c58bec2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215599
application number: ANDA215599

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886666flecainide acetate 100 MG Oral TabletPSN9aa3bd74-d8c3-4e40-a1be-19111492b6521
886666flecainide acetate 100 MG Oral TabletSCD9aa3bd74-d8c3-4e40-a1be-19111492b6521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7316-05009073160060 TABLET in 1 BOTTLE (50090-7316-0) 60 tablet2024-10-14NoNoHistorical