Propafenone Hydrochloride

Product NDC: 0603-5449
11-digit product format: 006035449
Labeler code: 0603
Product ID: 0603-5449_b375fca8-7731-4563-a237-2b066af75310
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Propafenone Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA075938
Marketing category: ANDA
Marketing start: 2002-10-17
Marketing end: 2024-04-30
Substance: PROPAFENONE HYDROCHLORIDE
Active strength: 225 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	0603-5449		D	Discontinued by firm	2026-08-10
excluded package	package	0603-5449	0603-5449-21	D	Discontinued by firm	2026-08-10
excluded package	package	0603-5449	0603-5449-25	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	0603-5449-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0603-5449-25	`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	0603-5449-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0603-5449-25	`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	0603-5449-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0603-5449-25	`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	0603-5449-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0603-5449-25	`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	0603-5449-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0603-5449-25	`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	0603-5449-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0603-5449-25	`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	0603-5449-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-5449-25	`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	0603-5449-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-5449-25	`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	0603-5449-21	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-5449-25	`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	0603-5449-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-5449-25	`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	0603-5449-21	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-5449-25	`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	0603-5449-21	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-5449-25	`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	RLD / RS	Approval date
A075938-001	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17
A075938-002	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17
A075938-003	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075938-001	AB
A075938-002	AB
A075938-003	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	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`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	A075938-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075938-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075938-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075938-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075938-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075938-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075938-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075938-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075938-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075938-001	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0603-5449-21	2022-08-25	These highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE TABLETS. PROPAFENONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1989
0603-5449-25	2022-08-25	These highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE TABLETS. PROPAFENONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1989
0603-5449-21	2022-07-29	These highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE TABLETS. PROPAFENONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1989
0603-5449-25	2022-07-29	These highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE TABLETS. PROPAFENONE HYDROCHLORIDE tablets, 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
0603-5449-21	EA - Each	0603-5449	70bcca2a-94bb-46b6-babd-ce0d457afd45	1	2012-07-24
0603-5449-25	EA - Each	0603-5449	79c8560a-5ebc-4075-a546-20a7771e347f	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 TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	7
PROPAFENONE	ACTIVE MOIETY	68IQX3T69U	PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	7
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	7
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	7
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	7
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	7

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	American Health Packaging	da08c286-b930-463a-858a-efc54f12019f	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075938 application number: ANDA075938
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	American Health Packaging	343e4ad7-05e2-4e6c-8f8e-91c07739cae2	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075938 application number: ANDA075938
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	c65253ab-937f-4982-b841-69c2b9f9ccdb	2025-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075938 application number: ANDA075938
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	a96f9c6f-4c9c-4406-bca8-08bf9a4af1f4	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075938 application number: ANDA075938

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
861427	propafenone HCl 225 MG Oral Tablet	PSN	5b3890cc-9078-4e11-b396-a26f75da3eb2	7
861427	propafenone hydrochloride 225 MG Oral Tablet	SCD	5b3890cc-9078-4e11-b396-a26f75da3eb2	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-5449-21	00603544921	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5449-21)	2002-10-17	0000-00-00	No	No	Current
0603-5449-25	00603544925	300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5449-25)	2002-10-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propafenone Hydrochloride	Bryant Ranch Prepack	2023-03-02	HUMAN PRESCRIPTION DRUG LABEL	102
Propafenone Hydrochloride	Par Pharmaceutical, Inc.	2022-08-23	HUMAN PRESCRIPTION DRUG LABEL	16
Propafenone Hydrochloride	Bryant Ranch Prepack	2022-04-20	HUMAN PRESCRIPTION DRUG LABEL	101
Propafenone Hydrochloride	A-S Medication Solutions	2021-06-15	HUMAN PRESCRIPTION DRUG LABEL	7