Flecainide Acetate

Product NDC: 71335-1487
Requested package NDC: 71335-1487-4
11-digit product format: 713351487
Labeler code: 71335
Product ID: 71335-1487_f0ea084d-e915-46dd-a726-56dbce934a27
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flecainide Acetate
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075882
Marketing category: ANDA
Marketing start: 2015-12-28
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	Approval date
A075882-001	FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2002-10-28
A075882-002	FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2002-10-28
A075882-003	FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2002-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075882-001	AB
A075882-002	AB
A075882-003	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	A075882-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2002-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075882-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2002-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075882-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2002-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075882-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2002-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075882-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2002-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075882-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2002-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075882-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2002-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075882-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2002-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075882-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2002-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075882-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2002-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075882-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2002-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075882-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2002-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075882-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2002-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075882-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2002-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075882-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2002-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075882-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2002-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075882-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2002-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075882-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2002-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075882-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2002-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075882-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2002-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075882-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2002-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075882-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2002-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075882-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2002-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075882-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2002-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075882-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2002-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075882-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2002-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075882-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2002-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075882-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2002-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075882-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2002-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075882-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2002-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075882-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2002-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075882-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2002-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075882-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2002-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075882-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2002-10-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075882-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2002-10-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075882-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2002-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075882-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2002-10-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075882-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2002-10-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075882-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2002-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075882-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2002-10-28	`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	A075882-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075882-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075882-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075882-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075882-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075882-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075882-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075882-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075882-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075882-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075882-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075882-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075882-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075882-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075882-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075882-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075882-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075882-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075882-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075882-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075882-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075882-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075882-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075882-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075882-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075882-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075882-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075882-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075882-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075882-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075882-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075882-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075882-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075882-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075882-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075882-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075882-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075882-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075882-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075882-001	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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
886662	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
f0416c8c-faae-4e31-aa50-1fb7df10abf0	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	SPL version
71335-1487-1	Flecainide Acetate	30 in 1 BOTTLE	TABLET	30	5
71335-1487-2	Flecainide Acetate	60 in 1 BOTTLE	TABLET	60	5
71335-1487-3	Flecainide Acetate	90 in 1 BOTTLE	TABLET	90	5
71335-1487-4	Flecainide Acetate	10 in 1 BOTTLE	TABLET	10	5
71335-1487-5	Flecainide Acetate	180 in 1 BOTTLE	TABLET	180	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1487	FLECAINIDE ACETATE TABLET [BRYANT RANCH PREPACK]	4	Current NDC, Legacy NDC, 5 package rows	20240526_f0416c8c-faae-4e31-aa50-1fb7df10abf0.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 · 13 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	1a2a5e08-2697-4a00-94fe-de07148acbd9	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075882 application number: ANDA075882
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Bryant Ranch Prepack	bc304b04-9373-4e47-905d-6b3367ad3be7	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075882 application number: ANDA075882
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Bryant Ranch Prepack	d34fae51-3658-4456-b3ea-1217f0f52260	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075882 application number: ANDA075882
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Bryant Ranch Prepack	cf143926-439b-4005-be0e-1e049b44c044	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075882 application number: ANDA075882
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	f0416c8c-faae-4e31-aa50-1fb7df10abf0	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075882 application number: ANDA075882 ndc (package): 71335-1487-4 ndc (product): 71335-1487 ndc11 (package): 71335148704
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Bryant Ranch Prepack	9929c166-8ba3-4159-a5f9-4618d5d227b0	2025-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075882 application number: ANDA075882
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Golden State Medical Supply, Inc.	74355cd2-b50e-0dc2-e053-2a91aa0aa164	2025-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075882 application number: ANDA075882
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Bryant Ranch Prepack	8dc86db1-2a09-4625-80eb-ff6ce9de2d7a	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075882 application number: ANDA075882
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Bryant Ranch Prepack	2028149f-6fc0-455c-bac5-729eeaa4aee5	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075882 application number: ANDA075882
Flecainide Acetate	FLECAINIDE ACETATE TABLET	ANI Pharmaceuticals, Inc.	5a12889a-52ce-4dc4-9240-22d126f071ac	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075882 application number: ANDA075882
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Proficient Rx LP	ee590951-cce8-4a1e-b3bd-ae0b610ebda9	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075882 application number: ANDA075882
Flecainide Acetate	FLECAINIDE ACETATE	A-S Medication Solutions	179e3821-0342-4b84-96bb-3fcab213d74f	2023-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075882 application number: ANDA075882
Flecainide Acetate	FLECAINIDE ACETATE TABLET	Bryant Ranch Prepack	5dc5b522-f16f-4b3b-b325-f4ace495f966	2023-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075882 application number: ANDA075882

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
886662	flecainide acetate 50 MG Oral Tablet	PSN	f0416c8c-faae-4e31-aa50-1fb7df10abf0	5
886662	flecainide acetate 50 MG Oral Tablet	SCD	f0416c8c-faae-4e31-aa50-1fb7df10abf0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1487-4	71335148704	10 TABLET in 1 BOTTLE (71335-1487-4)	10 tablet	2021-12-28	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	2025-09-23	HUMAN PRESCRIPTION DRUG LABEL	5