Flecainide Acetate

Product NDC: 50090-5267
Requested package NDC: 50090-5267-0
11-digit product format: 500905267
Labeler code: 50090
Product ID: 50090-5267_0f19825f-f583-4763-98b1-d16aea5fa1dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flecainide Acetate
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA202821
Marketing category: ANDA
Marketing start: 2015-07-08
Marketing end: 0000-00-00
Substance: FLECAINIDE ACETATE
Active strength: 100 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-5267	50090-5267-0	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5267-0	2023-02-07	C162847	48780-1	f386c64a-2f51-0266-e053-dadaa90a7c1a	Flecainide Acetate Tablets, USP Rx only
50090-5267-0	2023-01-30	C162847	48780-1	f386c64a-2f51-0266-e053-dadaa90a7c1a	Flecainide Acetate Tablets, USP Rx only

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5267-0	50090526700	60 TABLET in 1 BOTTLE (50090-5267-0)	60 tablet	2020-10-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Flecainide Acetate Tablets, USP Rx only	A-S Medication Solutions	2023-02-06	Human Prescription Drug Label	5