Flecainide Acetate

Product NDC: 53746-641
Requested package NDC: 53746-641-01
11-digit product format: 537460641
Labeler code: 53746
Product ID: 53746-641_e9e0eab5-efc5-4bac-8d46-0bce60b2fcc5
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: 50 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
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.

Application-product, TE code table
Application-product	TE code
A075442-001	AB
A075442-002	AB
A075442-003	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 4 · 129 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	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075442-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075442-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075442-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2001-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075442-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2001-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075442-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2001-07-31	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A075442-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075442-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075442-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075442-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075442-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075442-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075442-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075442-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075442-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075442-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075442-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075442-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075442-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075442-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075442-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075442-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075442-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075442-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075442-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075442-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075442-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075442-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075442-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075442-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075442-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075442-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075442-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075442-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075442-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075442-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075442-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075442-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075442-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075442-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075442-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075442-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075442-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075442-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075442-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075442-001	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	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ee9595d5-08a1-4529-9215-ddc3c7f929c4	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
53746-641-01	Flecainide Acetate	100 in 1 BOTTLE	TABLET	100		9
53746-641-10	Flecainide Acetate	1000 in 1 BOTTLE	TABLET	1000		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53746-641-01	EA - Each	53746-641	a0c25c94-576c-4c39-85c8-cf152855b4aa	1	2018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLECAINIDE ACETATE	ACTIVE INGREDIENT	M8U465Q1WQ	FLECAINIDE ACETATE TABLET [AVPAK]	1
FLECAINIDE	ACTIVE MOIETY	K94FTS1806	FLECAINIDE ACETATE TABLET [AVPAK]	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	FLECAINIDE ACETATE TABLET [AVPAK]	1
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	FLECAINIDE ACETATE TABLET [AVPAK]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	FLECAINIDE ACETATE TABLET [AVPAK]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53746-641	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flecainide Acetate	FLECAINIDE ACETATE	Amneal Pharmaceuticals of New York LLC	ee9595d5-08a1-4529-9215-ddc3c7f929c4	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075442 application number: ANDA075442 ndc (package): 53746-641-01 ndc (product): 53746-641 ndc11 (package): 53746064101
Flecainide Acetate	FLECAINIDE ACETATE	AvPAK	f53e1a49-6185-6db4-c867-ffd1241a8cb7	2026-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075442 application number: ANDA075442
Flecainide Acetate	FLECAINIDE ACETATE	A-S Medication Solutions	166aa9e4-3402-4ebd-baa5-07a8da8aae56	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075442 application number: ANDA075442
Flecainide Acetate	FLECAINIDE ACETATE	Amneal Pharmaceuticals LLC	d462d58e-fc3c-4c92-a210-e135eb1f4b77	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075442 application number: ANDA075442

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	ee9595d5-08a1-4529-9215-ddc3c7f929c4	9
886666	flecainide acetate 100 MG Oral Tablet	PSN	f53e1a49-6185-6db4-c867-ffd1241a8cb7	9
886671	flecainide acetate 150 MG Oral Tablet	PSN	ee9595d5-08a1-4529-9215-ddc3c7f929c4	9
886671	flecainide acetate 150 MG Oral Tablet	PSN	f53e1a49-6185-6db4-c867-ffd1241a8cb7	9
886662	flecainide acetate 50 MG Oral Tablet	PSN	ee9595d5-08a1-4529-9215-ddc3c7f929c4	9
886662	flecainide acetate 50 MG Oral Tablet	PSN	f53e1a49-6185-6db4-c867-ffd1241a8cb7	9
886666	flecainide acetate 100 MG Oral Tablet	SCD	ee9595d5-08a1-4529-9215-ddc3c7f929c4	9
886666	flecainide acetate 100 MG Oral Tablet	SCD	f53e1a49-6185-6db4-c867-ffd1241a8cb7	9
886671	flecainide acetate 150 MG Oral Tablet	SCD	ee9595d5-08a1-4529-9215-ddc3c7f929c4	9
886671	flecainide acetate 150 MG Oral Tablet	SCD	f53e1a49-6185-6db4-c867-ffd1241a8cb7	9
886662	flecainide acetate 50 MG Oral Tablet	SCD	ee9595d5-08a1-4529-9215-ddc3c7f929c4	9
886662	flecainide acetate 50 MG Oral Tablet	SCD	f53e1a49-6185-6db4-c867-ffd1241a8cb7	9
886662	flecainide acetate 50 MG Oral Tablet	PSN	166aa9e4-3402-4ebd-baa5-07a8da8aae56	3
886662	flecainide acetate 50 MG Oral Tablet	SCD	166aa9e4-3402-4ebd-baa5-07a8da8aae56	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53746-641-01	53746064101	100 TABLET in 1 BOTTLE (53746-641-01)	100 tablet	2009-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Flecainide Acetate Tablets, USP (50 mg, 100 mg and 150 mg) Rx only	Amneal Pharmaceuticals of New York LLC \| Amneal Pharmaceuticals Private Limited	2026-06-11	HUMAN PRESCRIPTION DRUG LABEL	11
Flecainide Acetate Tablets, USP Rx only	AvPAK	2026-01-11	HUMAN PRESCRIPTION DRUG LABEL	9
Flecainide Acetate Tablets, USP (50 mg, 100 mg and 150 mg) Rx only	A-S Medication Solutions	2026-01-06	HUMAN PRESCRIPTION DRUG LABEL	3