Propafenone Hydrochloride

Product NDC: 49884-210
11-digit product format: 498840210
Labeler code: 49884
Product ID: 49884-210_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: 325 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	49884-210		D	Discontinued by firm	2026-08-10
excluded package	package	49884-210	49884-210-01	D	Discontinued by firm	2026-08-10
excluded package	package	49884-210	49884-210-02	D	Discontinued by firm	2026-08-10
excluded package	package	49884-210	49884-210-05	D	Discontinued by firm	2026-08-10
excluded package	package	49884-210	49884-210-09	D	Discontinued by firm	2026-08-10
excluded package	package	49884-210	49884-210-10	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 · 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	49884-210-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-210-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-210-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-210-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-210-05	`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	49884-210-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49884-210-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49884-210-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49884-210-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49884-210-05	`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	49884-210-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49884-210-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49884-210-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49884-210-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49884-210-05	`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	49884-210-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49884-210-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49884-210-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49884-210-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49884-210-05	`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	49884-210-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-210-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-210-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-210-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-210-05	`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	49884-210-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-210-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-210-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-210-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-210-05	`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	49884-210-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-210-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-210-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-210-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-210-05	`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	49884-210-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-210-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-210-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-210-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-210-05	`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	49884-210-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-210-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-210-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-210-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-210-05	`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	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 · 123 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078540-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078540-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078540-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078540-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2010-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078540-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-10-18	`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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078540-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078540-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078540-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078540-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078540-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078540-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
559c7edd-6d87-934f-8fcc-0cd5e9651949	Product name	7	20240226
06783798-d93a-d4be-8416-24bb30819d48	Product name	2	20160630

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-210-02	EA - Each	49884-210	b4325fd3-793a-4c74-800e-bea24f30e583	1	2012-07-24
49884-210-05	EA - Each	49884-210	0e6a8349-241b-46b6-93ee-94d143d64f3f	1	2012-07-24
49884-210-09	EA - Each	49884-210	933549ac-fbeb-4c2d-8649-3e21acf74570	1	2013-02-13

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]	5
PROPAFENONE	ACTIVE MOIETY	68IQX3T69U	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	5
PROPAFENONE	ACTIVE INGREDIENT	68IQX3T69U	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
PROPAFENONE	ACTIVE MOIETY	68IQX3T69U	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
ETHANOL	INACTIVE INGREDIENT	3K9958V90M	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE BLACK	INACTIVE INGREDIENT	XM0M87F357	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROPAFENONE (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1

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	Strides Pharma Science Limited	3fc0800c-c063-48f8-ab4e-9aa9a4c3841f	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078540 application number: ANDA078540

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861164	propafenone HCl 325 MG 12HR Extended Release Oral Capsule	PSN	e4412a6a-ed4d-410d-8abb-86e1d7b72a3c	1
861164	12 HR propafenone hydrochloride 325 MG Extended Release Oral Capsule	SCD	e4412a6a-ed4d-410d-8abb-86e1d7b72a3c	1
861164	propafenone hydrochloride 325 MG 12 HR Extended Release Oral Capsule	SY	e4412a6a-ed4d-410d-8abb-86e1d7b72a3c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-210-01	49884021001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-210-01)	2011-01-03	0000-00-00	No	No	Current
49884-210-02	49884021002	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-210-02)	2011-01-03	2024-09-30	No	No	Current
49884-210-05	49884021005	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-210-05)	2011-01-03	2023-12-31	No	No	Current
49884-210-09	49884021009	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-210-09)	2011-01-03	2024-09-30	No	No	Current
49884-210-10	49884021010	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-210-10)	2011-01-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propafenone Hydrochloride	American Health Packaging	2023-02-07	HUMAN PRESCRIPTION DRUG LABEL	11
Propafenone Hydrochloride	Golden State Medical Supply, Inc.	2022-09-01	HUMAN PRESCRIPTION DRUG LABEL	5
Propafenone Hydrochloride	Bryant Ranch Prepack	2022-04-20	HUMAN PRESCRIPTION DRUG LABEL	101
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	Par Pharmaceutical, Inc.	2019-10-28	HUMAN PRESCRIPTION DRUG LABEL	21
PROPAFENONE HYDROCHLORIDE EXTENDED RELEASE CAPSULES	Rebel Distributors Corp	2011-04-13	HUMAN PRESCRIPTION DRUG LABEL	1