Flecainide Acetate

Product NDC: 42806-818
Requested package NDC: 42806-818-01
11-digit product format: 428060818
Labeler code: 42806
Product ID: 42806-818_52eef22b-3545-b398-e063-6394a90aec29
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	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.

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

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 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215599-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215599-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215599-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2022-09-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215599-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2022-09-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215599-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2022-09-08	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215599-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215599-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215599-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215599-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215599-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215599-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215599-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215599-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215599-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215599-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215599-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215599-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215599-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215599-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215599-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215599-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215599-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215599-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215599-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215599-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215599-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215599-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215599-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215599-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215599-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215599-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215599-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215599-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215599-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215599-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215599-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215599-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215599-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215599-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215599-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215599-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215599-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215599-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215599-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215599-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
47936aaf-dd8f-a65f-335e-74a6c45bbd64	Product name	5	20231128

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42806-818-01	EA - Each	42806-818	330accc2-7b83-41b8-828d-d0bf993679c9	1	2023-03-13

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 (package): 42806-818-01 ndc (product): 42806-818 ndc11 (package): 42806081801
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M8U465Q1WQ	FLECAINIDE ACETATE	54143-56-5	FLECAINIDE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
886666	flecainide acetate 100 MG Oral Tablet	PSN	74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc	8
886671	flecainide acetate 150 MG Oral Tablet	PSN	74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc	8
886662	flecainide acetate 50 MG Oral Tablet	PSN	74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc	8
886666	flecainide acetate 100 MG Oral Tablet	SCD	74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc	8
886671	flecainide acetate 150 MG Oral Tablet	SCD	74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc	8
886662	flecainide acetate 50 MG Oral Tablet	SCD	74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc	8
886666	flecainide acetate 100 MG Oral Tablet	PSN	8a900f29-85e1-464c-ae9e-44dc7cf11f46	1
886666	flecainide acetate 100 MG Oral Tablet	PSN	9aa3bd74-d8c3-4e40-a1be-19111492b652	1
886666	flecainide acetate 100 MG Oral Tablet	SCD	8a900f29-85e1-464c-ae9e-44dc7cf11f46	1
886666	flecainide acetate 100 MG Oral Tablet	SCD	9aa3bd74-d8c3-4e40-a1be-19111492b652	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Flecainide Acetate Tablets, USP	Epic Pharma, LLC \| Yichang Humanwell Pharmaceutical Co,. Ltd. \| Yichang Humanwell Oral Solid Dosge Plant	2026-05-29	HUMAN PRESCRIPTION DRUG LABEL	8
Flecainide Acetate Tablets, USP	Bryant Ranch Prepack	2026-02-06	HUMAN PRESCRIPTION DRUG LABEL	1
Flecainide Acetate Tablets, USP	A-S Medication Solutions	2024-10-16	HUMAN PRESCRIPTION DRUG LABEL	1