Flecainide Acetate

Product NDC: 62135-661
11-digit product format: 621350661
Labeler code: 62135
Product ID: 62135-661_25893d71-9846-59aa-e063-6294a90a3f48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flecainide Acetate
Dosage form: TABLET
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA079164
Marketing category: ANDA
Marketing start: 2009-07-09
Substance: FLECAINIDE ACETATE
Active strength: 100 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	Approval date
A079164-001	FLECAINIDE ACETATE	FLECAINIDE ACETATE	50MG	TABLET / ORAL	2009-07-09
A079164-002	FLECAINIDE ACETATE	FLECAINIDE ACETATE	100MG	TABLET / ORAL	2009-07-09
A079164-003	FLECAINIDE ACETATE	FLECAINIDE ACETATE	150MG	TABLET / ORAL	2009-07-09

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079164-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	2009-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079164-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	2009-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079164-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	2009-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079164-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	2009-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079164-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	2009-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079164-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	2009-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079164-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	2009-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079164-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	2009-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079164-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	2009-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079164-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	2009-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079164-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	2009-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079164-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	2009-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079164-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	2009-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079164-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	2009-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079164-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	2009-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079164-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	2009-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079164-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	2009-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079164-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	2009-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079164-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	2009-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079164-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	2009-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079164-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	2009-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079164-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	2009-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079164-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	2009-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079164-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	2009-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079164-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	2009-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079164-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	2009-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079164-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	2009-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079164-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	2009-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079164-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	2009-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079164-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	2009-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079164-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	2009-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079164-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	2009-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079164-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	2009-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079164-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	2009-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079164-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	2009-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079164-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	2009-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079164-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	2009-07-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079164-002	FLECAINIDE ACETATE	100MG	TABLET / ORAL	2009-07-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079164-003	FLECAINIDE ACETATE	150MG	TABLET / ORAL	2009-07-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079164-001	FLECAINIDE ACETATE	50MG	TABLET / ORAL	2009-07-09	`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	100 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
a604aee4-30d5-4007-9882-98137d0d867f	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
62135-661-60	Flecainide Acetate	60 in 1 BOTTLE, GLASS	TABLET	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-661-60	EA - Each	62135-661	58c58796-c3e3-4c73-8937-22ae23f740a3	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-661	FLECAINIDE ACETATE TABLET [CHARTWELL RX, LLC]	2	Current NDC, 1 package rows	20241030_a604aee4-30d5-4007-9882-98137d0d867f.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flecainide Acetate	FLECAINIDE ACETATE	Chartwell RX, LLC	a604aee4-30d5-4007-9882-98137d0d867f	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079164 application number: ANDA079164 ndc (product): 62135-661

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	a604aee4-30d5-4007-9882-98137d0d867f	2
886671	flecainide acetate 150 MG Oral Tablet	PSN	a604aee4-30d5-4007-9882-98137d0d867f	2
886662	flecainide acetate 50 MG Oral Tablet	PSN	a604aee4-30d5-4007-9882-98137d0d867f	2
886666	flecainide acetate 100 MG Oral Tablet	SCD	a604aee4-30d5-4007-9882-98137d0d867f	2
886671	flecainide acetate 150 MG Oral Tablet	SCD	a604aee4-30d5-4007-9882-98137d0d867f	2
886662	flecainide acetate 50 MG Oral Tablet	SCD	a604aee4-30d5-4007-9882-98137d0d867f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-661-60	62135066160	60 TABLET in 1 BOTTLE, GLASS (62135-661-60)	60 tablet	2023-06-21	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	Chartwell RX, LLC	2024-10-28	HUMAN PRESCRIPTION DRUG LABEL	2