Flecainide Acetate

Product NDC: 72789-385
Requested package NDC: 72789-385-60
11-digit product format: 727890385
Labeler code: 72789
Product ID: 72789-385_4bc04d15-e3ce-d29c-e063-6294a90a0103
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: flecainide acetate
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA210683
Marketing category: ANDA
Marketing start: 2024-01-11
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 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
A210683-001	FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2020-09-16
A210683-002	FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2020-09-16
A210683-003	FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2020-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210683-001	AB
A210683-002	AB
A210683-003	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 · 111 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	A210683-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2020-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210683-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2020-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210683-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2020-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210683-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2020-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210683-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2020-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210683-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2020-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210683-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2020-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210683-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2020-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210683-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2020-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210683-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2020-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210683-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2020-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210683-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2020-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210683-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2020-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210683-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2020-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210683-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2020-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210683-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2020-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210683-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2020-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210683-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2020-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210683-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2020-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210683-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2020-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210683-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2020-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210683-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2020-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210683-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2020-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210683-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2020-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210683-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2020-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210683-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2020-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210683-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2020-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210683-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2020-09-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210683-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2020-09-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210683-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2020-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210683-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2020-09-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210683-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2020-09-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210683-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2020-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210683-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2020-09-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210683-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2020-09-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210683-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2020-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210683-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2020-09-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210683-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	AB	2020-09-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210683-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	AB	2020-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210683-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	AB	2020-09-16	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A210683-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210683-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210683-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210683-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210683-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210683-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210683-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210683-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210683-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210683-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210683-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210683-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210683-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210683-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210683-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210683-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210683-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210683-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210683-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210683-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210683-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210683-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210683-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210683-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210683-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210683-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210683-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210683-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210683-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210683-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210683-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210683-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210683-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210683-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210683-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210683-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210683-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210683-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210683-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210683-001	AB	1	`8072bd15b7f6…`

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 · 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
2b336028-1e13-4ef7-b75e-345bc9c06f9a	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
72789-385-01	Flecainide Acetate	100 in 1 BOTTLE, PLASTIC	TABLET	100	7
72789-385-60	Flecainide Acetate	60 in 1 BOTTLE, PLASTIC	TABLET	60	7
72789-385-93	Flecainide Acetate	180 in 1 BOTTLE, PLASTIC	TABLET	180	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-385-01	EA - Each	72789-385	d12bb8c1-06cf-4ee7-b9e1-1092e46a1d26	1	2024-04-05
72789-385-60	EA - Each	72789-385	f20b5584-458a-41a9-8ea1-0d47c4877892	1	2024-04-05
72789-385-93	EA - Each	72789-385	2c998bed-186e-469e-9ff3-106206425fad	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-385	FLECAINIDE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]	5	Current NDC, 3 package rows	20241206_2b336028-1e13-4ef7-b75e-345bc9c06f9a.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	Bryant Ranch Prepack	a30103c5-a261-49a5-a7b3-f43eb77e87b7	2026-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210683 application number: ANDA210683
Flecainide Acetate	FLECAINIDE ACETATE	PD-Rx Pharmaceuticals, Inc.	abcb261b-30ae-4eb1-baf0-e9667a2bd8cf	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210683 application number: ANDA210683
Flecainide Acetate	FLECAINIDE ACETATE	PD-Rx Pharmaceuticals, Inc.	2b336028-1e13-4ef7-b75e-345bc9c06f9a	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210683 application number: ANDA210683 ndc (package): 72789-385-60 ndc (product): 72789-385 ndc11 (package): 72789038560
Flecainide Acetate	FLECAINIDE ACETATE	PD-Rx Pharmaceuticals, Inc.	45d39dff-22d9-4c04-af26-0cffd41abaa8	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210683 application number: ANDA210683
Flecainide Acetate	FLECAINIDE ACETATE	UNICHEM PHARMACEUTICALS (USA), INC.	5b33e96a-8336-46c4-aac7-4a6c0039cc80	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210683 application number: ANDA210683
Flecainide Acetate	FLECAINIDE ACETATE	Bryant Ranch Prepack	bf810a3b-1a71-4a05-bf54-d5a6caba444b	2025-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210683 application number: ANDA210683

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	2b336028-1e13-4ef7-b75e-345bc9c06f9a	7
886662	flecainide acetate 50 MG Oral Tablet	SCD	2b336028-1e13-4ef7-b75e-345bc9c06f9a	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72789-385-60	72789038560	60 TABLET in 1 BOTTLE, PLASTIC (72789-385-60)	60 tablet	2024-02-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Flecainide Acetate Tablets USP	PD-Rx Pharmaceuticals, Inc.	2026-02-26	HUMAN PRESCRIPTION DRUG LABEL	7