Home NDC 42806-818 Flecainide Acetate
Product NDC 42806-818
11-digit product format 428060818
Labeler code 42806
Product ID 42806-818_44e0bf64-72e3-4168-e063-6294a90a3934
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name flecainide acetate
Dosage form TABLET
Route ORAL
Labeler Epic Pharma, LLC
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215599-001 FLECAINIDE ACETATE FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2022-09-08 A215599-002 FLECAINIDE ACETATE FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2022-09-08 A215599-003 FLECAINIDE ACETATE FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2022-09-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A215599-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2022-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215599-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2022-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215599-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2022-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215599-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2022-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215599-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2022-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215599-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2022-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215599-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2022-09-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215599-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2022-09-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215599-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2022-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215599-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2022-09-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215599-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2022-09-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215599-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2022-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215599-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2022-09-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215599-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2022-09-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215599-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2022-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215599-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2022-09-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215599-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2022-09-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215599-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2022-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215599-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2022-09-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215599-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2022-09-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215599-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2022-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215599-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2022-09-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215599-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2022-09-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215599-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2022-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215599-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2022-09-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215599-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2022-09-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215599-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2022-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215599-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2022-09-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215599-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2022-09-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215599-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2022-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215599-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2022-09-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215599-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2022-09-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215599-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2022-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215599-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2022-09-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215599-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2022-09-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215599-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2022-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215599-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2022-09-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215599-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2022-09-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215599-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2022-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215599-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2022-09-08 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 81 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Flecainide Acetate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLECAINIDE ACETATE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M8U465Q1WQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 886662 Internal RxNorm lookup 886666 Internal RxNorm lookup 886671 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42806-818-01 Flecainide Acetate 100 in 1 BOTTLE TABLET 100 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-818 FLECAINIDE ACETATE TABLET [EPIC PHARMA, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20240620_74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Flecainide Acetate FLECAINIDE ACETATE Epic Pharma, LLC 74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc 2026-05-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215599 application number: ANDA215599 ndc (product): 42806-818 Flecainide Acetate FLECAINIDE ACETATE Bryant Ranch Prepack 8a900f29-85e1-464c-ae9e-44dc7cf11f46 2026-02-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215599 application number: ANDA215599 Flecainide Acetate FLECAINIDE ACETATE Bryant Ranch Prepack 5cfa10ba-dfe8-42ab-81b3-8cca657aba07 2026-02-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215599 application number: ANDA215599 Flecainide Acetate FLECAINIDE ACETATE Bryant Ranch Prepack b821ec16-93ff-4569-9fbb-4f3842c58bec 2026-02-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215599 application number: ANDA215599
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42806-818-01 42806081801 100 TABLET in 1 BOTTLE (42806-818-01) 100 tablet 2022-09-15 0000-00-00 No No Current