Home NDC 0054-0010 Flecainide Acetate
Product NDC 0054-0010
11-digit product format 000540010
Labeler code 0054
Product ID 0054-0010_e34a6adf-8794-426e-9e43-11060803a90d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name flecainide acetate
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA076278
Marketing category ANDA
Marketing start 2003-01-14
Substance FLECAINIDE ACETATE
Active strength 50 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 A076278-001 FLECAINIDE ACETATE FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2003-01-14 A076278-002 FLECAINIDE ACETATE FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2003-01-14 A076278-003 FLECAINIDE ACETATE FLECAINIDE ACETATE 150MG TABLET / ORAL AB RS 2003-01-14
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 A076278-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2003-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076278-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2003-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076278-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB RS 2003-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076278-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2003-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076278-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2003-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076278-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB RS 2003-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076278-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2003-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076278-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2003-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076278-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB RS 2003-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076278-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2003-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076278-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2003-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076278-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB RS 2003-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076278-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2003-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076278-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2003-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076278-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB RS 2003-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076278-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2003-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076278-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2003-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076278-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB RS 2003-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076278-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2003-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076278-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2003-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076278-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB RS 2003-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076278-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2003-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076278-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2003-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076278-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB RS 2003-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076278-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2003-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076278-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2003-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076278-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB RS 2003-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076278-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2003-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076278-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2003-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076278-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB RS 2003-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076278-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2003-01-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076278-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2003-01-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076278-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB RS 2003-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076278-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2003-01-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076278-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2003-01-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076278-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB RS 2003-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076278-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2003-01-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076278-002 FLECAINIDE ACETATE 100MG TABLET / ORAL AB 2003-01-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076278-003 FLECAINIDE ACETATE 150MG TABLET / ORAL AB RS 2003-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076278-001 FLECAINIDE ACETATE 50MG TABLET / ORAL AB 2003-01-14 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 50 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 0054-0010-20 Flecainide Acetate 100 in 1 CARTON TABLET 100 11 0054-0010-20 Flecainide Acetate 1 in 1 BLISTER PACK TABLET 1 11 0054-0010-21 Flecainide Acetate 60 in 1 BOTTLE TABLET 60 11 0054-0010-25 Flecainide Acetate 100 in 1 BOTTLE TABLET 100 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLECAINIDE ACETATE ACTIVE INGREDIENT M8U465Q1WQ FLECAINIDE ACETATE TABLET [ROXANE LABORATORIES, INC.] 8 FLECAINIDE ACTIVE MOIETY K94FTS1806 FLECAINIDE ACETATE TABLET [ROXANE LABORATORIES, INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLECAINIDE ACETATE TABLET [ROXANE LABORATORIES, INC.] 8 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FLECAINIDE ACETATE TABLET [ROXANE LABORATORIES, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLECAINIDE ACETATE TABLET [ROXANE LABORATORIES, INC.] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLECAINIDE ACETATE TABLET [ROXANE LABORATORIES, INC.] 8 FLECAINIDE ACETATE ACTIVE INGREDIENT M8U465Q1WQ FLECAINIDE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 FLECAINIDE ACTIVE MOIETY K94FTS1806 FLECAINIDE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLECAINIDE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 COTTONSEED OIL INACTIVE INGREDIENT H3E878020N FLECAINIDE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FLECAINIDE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLECAINIDE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLECAINIDE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0010 FLECAINIDE ACETATE TABLET [HIKMA PHARMACEUTICALS USA INC.] 11 Current NDC, Legacy NDC, 4 package rows 20241206_4f6b78d4-8ac8-464b-bb78-ee70cbc97898.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 · 1 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 0054-0010-20 00054001020 100 BLISTER PACK in 1 CARTON (0054-0010-20) / 1 TABLET in 1 BLISTER PACK 100 blister pack 2003-01-14 0000-00-00 No No Current 0054-0010-21 00054001021 60 TABLET in 1 BOTTLE (0054-0010-21) 60 tablet 2003-01-14 0000-00-00 No No Current 0054-0010-25 00054001025 100 TABLET in 1 BOTTLE (0054-0010-25) 100 tablet 2003-01-14 0000-00-00 No No Current