Home NDC 53746-643 Flecainide Acetate
Product NDC 53746-643
11-digit product format 537460643
Labeler code 53746
Product ID 53746-643_fe4cd965-0740-40bc-a301-26e337c8406e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flecainide Acetate
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA075442
Marketing category ANDA
Marketing start 2009-12-01
Substance FLECAINIDE ACETATE
Active strength 150 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 A075442-001 FLECAINIDE ACETATE FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2001-07-31 A075442-002 FLECAINIDE ACETATE FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2001-07-31 A075442-003 FLECAINIDE ACETATE FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2001-07-31
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 4 · 123 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 A075442-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2001-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075442-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2001-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075442-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2001-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075442-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2001-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075442-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2001-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075442-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2001-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075442-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2001-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075442-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2001-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075442-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2001-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075442-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2001-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075442-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2001-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075442-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2001-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075442-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2001-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075442-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2001-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075442-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2001-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075442-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2001-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075442-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2001-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075442-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2001-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075442-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2001-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075442-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2001-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075442-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2001-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075442-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2001-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075442-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2001-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075442-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2001-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075442-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2001-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075442-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2001-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075442-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2001-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075442-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2001-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075442-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2001-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075442-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2001-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075442-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2001-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075442-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2001-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075442-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2001-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075442-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2001-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075442-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2001-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075442-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2001-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075442-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2001-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075442-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2001-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075442-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB 2001-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075442-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2001-07-31 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Flecainide Acetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLECAINIDE ACETATE 150 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 53746-643-01 Flecainide Acetate 100 in 1 BOTTLE TABLET 100 9 53746-643-10 Flecainide Acetate 1000 in 1 BOTTLE TABLET 1000 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-643 FLECAINIDE ACETATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 9 Current NDC, Legacy NDC, 2 package rows 20240101_ee9595d5-08a1-4529-9215-ddc3c7f929c4.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.
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 53746-643-01 53746064301 100 TABLET in 1 BOTTLE (53746-643-01) 100 tablet 2009-12-01 0000-00-00 No No Current 53746-643-10 53746064310 1000 TABLET in 1 BOTTLE (53746-643-10) 1000 tablet 2009-12-01 0000-00-00 No No Current