Flecainide Acetate

Product NDC: 57237-065
11-digit product format: 572370065
Labeler code: 57237
Product ID: 57237-065_c6b596c3-30c8-4bf6-89f6-03026358a3c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flecainide Acetate
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA202821
Marketing category: ANDA
Marketing start: 2015-07-08
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	Approval date
A202821-001	FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2017-11-03
A202821-002	FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2017-11-03
A202821-003	FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2017-11-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202821-001	AB
A202821-002	AB
A202821-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A202821-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2017-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202821-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2017-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202821-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2017-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202821-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2017-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202821-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2017-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202821-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2017-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202821-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2017-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202821-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2017-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202821-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2017-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202821-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2017-11-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202821-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2017-11-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202821-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2017-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202821-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2017-11-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202821-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2017-11-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202821-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2017-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202821-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2017-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202821-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2017-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202821-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2017-11-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202821-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2017-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202821-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2017-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202821-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2017-11-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202821-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2017-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202821-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2017-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202821-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2017-11-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202821-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2017-11-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202821-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2017-11-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202821-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2017-11-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202821-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2017-11-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202821-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2017-11-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202821-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2017-11-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202821-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2017-11-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202821-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2017-11-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202821-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2017-11-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202821-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2017-11-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202821-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2017-11-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202821-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2017-11-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202821-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2017-11-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202821-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2017-11-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202821-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2017-11-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202821-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2017-11-03	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202821-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202821-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202821-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202821-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202821-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202821-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202821-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202821-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202821-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202821-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202821-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202821-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202821-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202821-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202821-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202821-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202821-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202821-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202821-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202821-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202821-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202821-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202821-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202821-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202821-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202821-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202821-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202821-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202821-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202821-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202821-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202821-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202821-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202821-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202821-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202821-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202821-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202821-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202821-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202821-001	AB	1	`8072bd15b7f6…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e56335c1-5508-4136-bd2e-18385623e497	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
57237-065-01	Flecainide Acetate	100 in 1 BOTTLE	TABLET	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-065-01	EA - Each	57237-065	aba1beca-5696-43c2-9105-20156d6ca1a8	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLECAINIDE ACETATE	ACTIVE INGREDIENT	M8U465Q1WQ	FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC]	1
FLECAINIDE	ACTIVE MOIETY	K94FTS1806	FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC]	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLECAINIDE ACETATE TABLET [CITRON PHARMA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-065	FLECAINIDE ACETATE TABLET [RISING PHARMA HOLDINGS, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20240113_e56335c1-5508-4136-bd2e-18385623e497.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flecainide Acetate	FLECAINIDE ACETATE	A-S Medication Solutions	475a52a9-f18c-4a69-91f0-8f5e601f4336	2024-11-13	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 202821 application number: ANDA202821
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	6b73e32f-851b-4503-8296-e5db3a584b75	2024-05-24	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 202821 application number: ANDA202821
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	2013e6ef-9141-42c3-8ea8-285840ecdd15	2024-04-03	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 202821 application number: ANDA202821
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	5d6a4772-663e-468d-a8e1-4085e1b32bf7	2024-04-03	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 202821 application number: ANDA202821
Flecainide Acetate	FLECAINIDE ACETATE	Aurobindo Pharma Limited	14e89448-3a18-42e3-8537-2589be1ef94e	2024-01-09	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 202821 application number: ANDA202821
Flecainide Acetate	FLECAINIDE ACETATE	Rising Pharma Holdings, Inc.	e56335c1-5508-4136-bd2e-18385623e497	2024-01-09	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 202821 application number: ANDA202821 ndc (product): 57237-065

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
886671	flecainide acetate 150 MG Oral Tablet	PSN	6b73e32f-851b-4503-8296-e5db3a584b75	102
886671	flecainide acetate 150 MG Oral Tablet	SCD	6b73e32f-851b-4503-8296-e5db3a584b75	102
886666	flecainide acetate 100 MG Oral Tablet	PSN	e56335c1-5508-4136-bd2e-18385623e497	6
886671	flecainide acetate 150 MG Oral Tablet	PSN	e56335c1-5508-4136-bd2e-18385623e497	6
886662	flecainide acetate 50 MG Oral Tablet	PSN	e56335c1-5508-4136-bd2e-18385623e497	6
886666	flecainide acetate 100 MG Oral Tablet	SCD	e56335c1-5508-4136-bd2e-18385623e497	6
886671	flecainide acetate 150 MG Oral Tablet	SCD	e56335c1-5508-4136-bd2e-18385623e497	6
886662	flecainide acetate 50 MG Oral Tablet	SCD	e56335c1-5508-4136-bd2e-18385623e497	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-065-01	57237006501	100 TABLET in 1 BOTTLE (57237-065-01)	100 tablet	2015-07-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Flecainide Acetate Tablets, USP Rx only	Bryant Ranch Prepack	2024-05-24	HUMAN PRESCRIPTION DRUG LABEL	102
Flecainide Acetate Tablets, USP Rx only	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-01-09	Human Prescription Drug Label	6