FDA.reportPublic FDA data

FLECAINIDE ACETATE - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2023-11-28
Label type
Indexing - Product Concept
Version
5
Source
full-release
Hydrated at
2026-06-05 00:22:24

Label at a glance#

ProductFLECAINIDE ACETATE
Active ingredientFLECAINIDE ACETATE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
FLECAINIDE ACETATEM8U465Q1WQACTIB
FLECAINIDE ACETATEM8U465Q1WQACTIB
FLECAINIDE ACETATEM8U465Q1WQACTIB

Source Document#

Source XML

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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flecainide AcetateFLECAINIDE ACETATEAmneal Pharmaceuticals of New York LLCee9595d5-08a1-4529-9215-ddc3c7f929c42026-06-11Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEEpic Pharma, LLC74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc2026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepacka30103c5-a261-49a5-a7b3-f43eb77e87b72026-05-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEPD-Rx Pharmaceuticals, Inc.abcb261b-30ae-4eb1-baf0-e9667a2bd8cf2026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEPD-Rx Pharmaceuticals, Inc.2b336028-1e13-4ef7-b75e-345bc9c06f9a2026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEPD-Rx Pharmaceuticals, Inc.45d39dff-22d9-4c04-af26-0cffd41abaa82026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack8a900f29-85e1-464c-ae9e-44dc7cf11f462026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack5cfa10ba-dfe8-42ab-81b3-8cca657aba072026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepackb821ec16-93ff-4569-9fbb-4f3842c58bec2026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEUNICHEM PHARMACEUTICALS (USA), INC.5b33e96a-8336-46c4-aac7-4a6c0039cc802026-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEAvPAKf53e1a49-6185-6db4-c867-ffd1241a8cb72026-01-11Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEA-S Medication Solutions166aa9e4-3402-4ebd-baa5-07a8da8aae562026-01-06Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEA-S Medication Solutions1a2a5e08-2697-4a00-94fe-de07148acbd92025-11-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepackbc304b04-9373-4e47-905d-6b3367ad3be72025-11-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepackd34fae51-3658-4456-b3ea-1217f0f522602025-11-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepackcf143926-439b-4005-be0e-1e049b44c0442025-11-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepackf0416c8c-faae-4e31-aa50-1fb7df10abf02025-09-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepack9929c166-8ba3-4159-a5f9-4618d5d227b02025-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
Flecainide AcetateFLECAINIDE ACETATE TABLETGolden State Medical Supply, Inc.74355cd2-b50e-0dc2-e053-2a91aa0aa1642025-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepack8dc86db1-2a09-4625-80eb-ff6ce9de2d7a2025-08-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.