Application 019151

Type: NDA
Sponsor: GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RYTHMOL	PROPAFENONE HYDROCHLORIDE	TABLET;ORAL	150MG	Yes	No
002	RYTHMOL	PROPAFENONE HYDROCHLORIDE	TABLET;ORAL	300MG	Yes	No
003	RYTHMOL	PROPAFENONE HYDROCHLORIDE	TABLET;ORAL	225MG	Yes	No

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	RLD / RS	Approval date
N019151-001	RYTHMOL	PROPAFENONE HYDROCHLORIDE	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27
N019151-002	RYTHMOL	PROPAFENONE HYDROCHLORIDE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27
N019151-003	RYTHMOL	PROPAFENONE HYDROCHLORIDE	225MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-20

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 3 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-14 00:12 UTC	2019-12	N019151-003	RYTHMOL	225MG	TABLET / ORAL	RLD	1992-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019151-001	RYTHMOL	150MG	TABLET / ORAL	RLD	1989-11-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019151-002	RYTHMOL	300MG	TABLET / ORAL	RLD	1989-11-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019151-003	RYTHMOL	225MG	TABLET / ORAL	RLD	1992-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019151-001	RYTHMOL	150MG	TABLET / ORAL	RLD	1989-11-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019151-002	RYTHMOL	300MG	TABLET / ORAL	RLD	1989-11-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019151-003	RYTHMOL	225MG	TABLET / ORAL	RLD	1992-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019151-001	RYTHMOL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019151-002	RYTHMOL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019151-003	RYTHMOL	225MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019151-001	RYTHMOL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N019151-002	RYTHMOL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N019151-003	RYTHMOL	225MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019151-001	RYTHMOL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N019151-002	RYTHMOL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N019151-003	RYTHMOL	225MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019151-001	RYTHMOL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019151-002	RYTHMOL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019151-003	RYTHMOL	225MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019151-001	RYTHMOL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019151-002	RYTHMOL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019151-003	RYTHMOL	225MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019151-001	RYTHMOL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019151-002	RYTHMOL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019151-003	RYTHMOL	225MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019151-001	RYTHMOL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019151-002	RYTHMOL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019151-003	RYTHMOL	225MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019151-001	RYTHMOL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N019151-002	RYTHMOL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N019151-003	RYTHMOL	225MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019151-001	RYTHMOL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N019151-002	RYTHMOL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N019151-003	RYTHMOL	225MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019151-001	RYTHMOL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019151-002	RYTHMOL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019151-003	RYTHMOL	225MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019151-001	RYTHMOL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N019151-002	RYTHMOL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-11-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N019151-003	RYTHMOL	225MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-20	`f41ea6bd6efb…`

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
propafenone hydrochloride	PROPAFENONE HYDROCHLORIDE	Northstar Rx LLC	2ecd6452-ccc3-493f-9a4a-69f0fbf67a42	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	c8ad1f0f-0e95-4868-a2af-e193c1833841	2026-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	faa8e971-4b4f-43db-be97-33acc16dcdc7	2026-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	80f174e1-f249-4f34-806d-20e643084429	2026-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	A-S Medication Solutions	41b4e503-60a6-4662-a6f9-46ecf93d930a	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	680a803d-3d4d-4ca3-b1ce-7d7e3ff8a626	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	5c8cebcd-699f-4c4c-900b-94e0fe519345	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	739b7624-952d-4343-b720-974d30e284d9	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
propafenone hydrochloride	PROPAFENONE HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	d818af31-2535-4595-82fe-fd7abf66fd6c	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	8aa6f58a-2980-4caa-9c54-d55d69d5d132	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Golden State Medical Supply, Inc.	7202aed6-40a9-2bff-e053-2a95a90ae752	2025-11-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	a6ac2a70-e0ec-4fcd-8732-5f1637be1e60	2025-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	American Health Packaging	da08c286-b930-463a-858a-efc54f12019f	2025-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	617faff7-d9e4-477d-ab2c-aded5c129a86	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	American Health Packaging	343e4ad7-05e2-4e6c-8f8e-91c07739cae2	2025-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	8d1be333-be2b-4064-86a4-c2ad9ad07b83	2025-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	c65253ab-937f-4982-b841-69c2b9f9ccdb	2025-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	a96f9c6f-4c9c-4406-bca8-08bf9a4af1f4	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Aurobindo Pharma Limited	1c4fc726-3f5b-4b12-a66e-727c5133d1d9	2025-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	9da7e6d2-64da-43cd-9575-b2b0d5d412dc	2024-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROPAFENONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56326	SUPPL	2018-11-07
56255	SUPPL	2018-11-02
33701	SUPPL	2013-03-26
1236	SUPPL	2013-03-22
1235	SUPPL	2004-06-16
1234	SUPPL	2002-12-05
20208	SUPPL	1997-12-23