Propafenone Hydrochloride

Product NDC: 49884-113
11-digit product format: 498840113
Labeler code: 49884
Product ID: 49884-113_b87c7717-5019-43fe-9a18-d2d7ae07cc91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: propafenone hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA078540
Marketing category: ANDA
Marketing start: 2011-01-03
Marketing end: 0000-00-00
Substance: PROPAFENONE HYDROCHLORIDE
Active strength: 225 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49884-113		D	Discontinued by firm	2026-10-05
excluded package	package	49884-113	49884-113-01	D	Discontinued by firm	2026-10-05
excluded package	package	49884-113	49884-113-02	D	Discontinued by firm	2026-10-05
excluded package	package	49884-113	49884-113-05	D	Discontinued by firm	2026-10-05
excluded package	package	49884-113	49884-113-09	D	Discontinued by firm	2026-10-05
excluded package	package	49884-113	49884-113-10	D	Discontinued by firm	2026-10-05

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 · 54 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	49884-113-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-113-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-113-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-113-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-113-05	`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	49884-113-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49884-113-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49884-113-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49884-113-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49884-113-05	`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	49884-113-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49884-113-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49884-113-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49884-113-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49884-113-05	`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	49884-113-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49884-113-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49884-113-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49884-113-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49884-113-05	`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	49884-113-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-113-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-113-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-113-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-113-05	`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	49884-113-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-113-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-113-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-113-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-113-05	`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	49884-113-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-113-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-113-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-113-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-113-05	`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	49884-113-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-113-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-113-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-113-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-113-05	`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	49884-113-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-113-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-113-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-113-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-113-05	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
A078540-001	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18
A078540-002	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18
A078540-003	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078540-001	AB
A078540-002	AB
A078540-003	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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078540-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078540-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078540-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078540-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078540-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078540-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078540-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078540-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078540-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078540-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078540-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078540-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078540-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078540-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078540-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078540-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078540-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078540-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078540-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078540-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078540-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078540-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078540-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078540-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078540-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078540-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078540-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078540-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078540-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078540-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078540-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078540-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078540-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078540-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078540-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078540-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078540-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078540-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078540-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078540-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078540-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078540-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078540-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078540-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078540-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078540-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078540-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078540-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078540-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078540-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078540-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078540-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078540-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078540-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078540-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078540-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078540-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078540-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078540-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078540-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078540-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078540-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078540-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078540-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078540-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078540-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-113-02	EA - Each	49884-113	c6e7d915-0e38-4963-8080-ac3570fc6f97	1	2015-09-10
49884-113-05	EA - Each	49884-113	1179e276-b2b9-4da3-be8e-7ab249aa6c65	1	2015-04-03
49884-113-09	EA - Each	49884-113	7a021ac4-1316-4b91-baaa-affeae70946a	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROPAFENONE HYDROCHLORIDE	ACTIVE INGREDIENT	33XCH0HOCD	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
PROPAFENONE	ACTIVE MOIETY	68IQX3T69U	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	13
PROPAFENONE HYDROCHLORIDE	ACTIVE INGREDIENT	33XCH0HOCD	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
PROPAFENONE	ACTIVE MOIETY	68IQX3T69U	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33XCH0HOCD	PROPAFENONE HYDROCHLORIDE	34183-22-7	PROPAFENONE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-113-01	49884011301	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-113-01)	2011-01-03	0000-00-00	No	No	Current
49884-113-02	49884011302	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-113-02)	2015-08-11	2024-09-30	No	No	Current
49884-113-05	49884011305	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-113-05)	2015-03-19	2023-01-31	No	No	Current
49884-113-09	49884011309	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-113-09)	2015-06-19	2024-09-30	No	No	Current
49884-113-10	49884011310	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-113-10)	2011-01-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propafenone Hydrochloride	Bryant Ranch Prepack	2023-02-27	HUMAN PRESCRIPTION DRUG LABEL	103
Propafenone Hydrochloride	American Health Packaging	2023-02-07	HUMAN PRESCRIPTION DRUG LABEL	7
Propafenone Hydrochloride	Bryant Ranch Prepack	2022-04-20	HUMAN PRESCRIPTION DRUG LABEL	101
Propafenone Hydrochloride	AvKARE, Inc.	2022-01-28	HUMAN PRESCRIPTION DRUG LABEL	5
Propafenone Hydrochloride	Golden State Medical Supply	2020-03-24	HUMAN PRESCRIPTION DRUG LABEL	4
Propafenone Hydrochloride	Par Pharmaceutical, Inc.	2019-10-28	HUMAN PRESCRIPTION DRUG LABEL	21