RYTHMOL

Product NDC: 0173-0824
11-digit product format: 001730824
Labeler code: 0173
Product ID: 0173-0824_5289b871-0c92-4a43-839e-b405d298f477
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: propafenone hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: GlaxoSmithKline LLC
Application: NDA021416
Marketing category: NDA
Marketing start: 2011-03-17
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0173-0824		D	Discontinued by firm		2026-08-10
excluded package	package	0173-0824	0173-0824-18	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 · 18 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	0173-0824-18	`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	0173-0824-18	`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	0173-0824-18	`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	0173-0824-18	`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	0173-0824-18	`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	0173-0824-18	`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	0173-0824-18	`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	0173-0824-18	`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	0173-0824-18	`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	RLD / RS	Approval date
N021416-001	RYTHMOL SR	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04
N021416-002	RYTHMOL SR	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04
N021416-003	RYTHMOL SR	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021416-002	RYTHMOL SR	325MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021416-003	RYTHMOL SR	425MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021416-001	RYTHMOL SR	225MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2003-09-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021416-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021416-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021416-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021416-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021416-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021416-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021416-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021416-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021416-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021416-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021416-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021416-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021416-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021416-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021416-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021416-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021416-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021416-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021416-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021416-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021416-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021416-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021416-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021416-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021416-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021416-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021416-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021416-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021416-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021416-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021416-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021416-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021416-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021416-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021416-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021416-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021416-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021416-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021416-003	AB	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021416-001	AB	1	`a72a2bbeb626…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0173-0824-18	EA - Each	0173-0824	e78075ca-f670-4caf-8d54-09e433acbbd9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROPAFENONE HYDROCHLORIDE	ACTIVE INGREDIENT	33XCH0HOCD	RYTHMOL SR (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	16
PROPAFENONE	ACTIVE MOIETY	68IQX3T69U	RYTHMOL SR (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	16
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RYTHMOL SR (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	16
GELATIN	INACTIVE INGREDIENT	2G86QN327L	RYTHMOL SR (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	16
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RYTHMOL SR (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	16
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	RYTHMOL SR (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	16
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RYTHMOL SR (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	16
SHELLAC	INACTIVE INGREDIENT	46N107B71O	RYTHMOL SR (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	16
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RYTHMOL SR (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	16
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RYTHMOL SR (PROPAFENONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	16

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
0173-0824-18	00173082418	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0173-0824-18)	2011-03-17	0000-00-00	No	No	Current