PROPAFENONE HYDROCHLORIDE

Product NDC: 52536-733
11-digit product format: 525360733
Labeler code: 52536
Product ID: 52536-733_5f7e4969-d2c4-4871-863b-34f2585a3cda
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROPAFENONE HYDROCHLORIDE
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Wilshire Pharmaceuticals
Application: ANDA205956
Marketing category: ANDA
Marketing start: 2019-03-21
Marketing end: 0000-00-00
Substance: PROPAFENONE HYDROCHLORIDE
Active strength: 325 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52536-733		D	Discontinued by firm	2026-08-10
excluded package	package	52536-733	52536-733-06	D	Discontinued by firm	2026-08-10
excluded package	package	52536-733	52536-733-50	D	Discontinued by firm	2026-08-10

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52536-733-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52536-733-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52536-733-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52536-733-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52536-733-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52536-733-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52536-733-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52536-733-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52536-733-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52536-733-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52536-733-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52536-733-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52536-733-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52536-733-06	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52536-733-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52536-733-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52536-733-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52536-733-06	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52536-733-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52536-733-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52536-733-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52536-733-06	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52536-733-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52536-733-06	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A205956-001	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02
A205956-002	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02
A205956-003	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205956-001	AB
A205956-002	AB
A205956-003	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	A205956-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205956-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205956-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205956-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205956-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205956-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205956-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205956-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205956-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205956-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205956-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205956-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205956-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205956-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205956-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205956-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205956-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205956-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205956-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205956-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205956-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205956-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205956-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205956-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205956-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205956-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205956-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205956-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205956-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205956-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205956-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205956-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205956-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205956-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205956-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205956-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205956-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205956-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205956-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205956-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-07-02	`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	A205956-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205956-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205956-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205956-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205956-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205956-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205956-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205956-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205956-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205956-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205956-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205956-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205956-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205956-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205956-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205956-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205956-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205956-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205956-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205956-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205956-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205956-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205956-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205956-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205956-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205956-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205956-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205956-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205956-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205956-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205956-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205956-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205956-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205956-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205956-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205956-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205956-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205956-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205956-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205956-001	AB	1	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
52536-733-06	2021-09-30	These highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. PROPAFENONE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1989
52536-733-50	2021-09-30	These highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. PROPAFENONE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1989
52536-733-06	2021-01-29	These highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. PROPAFENONE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1989
52536-733-50	2021-01-29	These highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. PROPAFENONE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1989

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52536-733-06	EA - Each	52536-733	1d9112d1-ae6d-4382-927f-56b87d13fa44	1	2019-10-07

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
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	36cf4555-6fe9-42d8-8d3b-3ca9c134a5b8	2020-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205956 application number: ANDA205956