ropinirole hydrochloride

Product NDC: 43353-194
11-digit product format: 433530194
Labeler code: 43353
Product ID: 43353-194_f70e20d8-079c-48fa-9dde-acc3025d487e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ropinirole hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA078110
Marketing category: ANDA
Marketing start: 2011-09-20
Marketing end: 0000-00-00
Substance: ROPINIROLE HYDROCHLORIDE
Active strength: 0 mg/1
Pharmacologic classes: Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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	43353-194		I	Inactivated by FDA		2026-08-17
excluded package	package	43353-194	43353-194-09	I	Inactivated by FDA		2026-08-17

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 · 42 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	43353-194-09	`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	43353-194-09	`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	43353-194-09	`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	43353-194-09	`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	43353-194-09	`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	43353-194-09	`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	43353-194-09	`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	43353-194-09	`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	43353-194-09	`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	43353-194-09	`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	43353-194-09	`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	43353-194-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-194-09	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-194-09	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-194-09	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43353-194-09	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43353-194-09	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43353-194-09	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43353-194-09	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43353-194-09	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43353-194-09	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078110-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05
A078110-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05
A078110-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05
A078110-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05
A078110-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05
A078110-006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05
A078110-007	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A078110-001	AB
A078110-002	AB
A078110-003	AB
A078110-004	AB
A078110-005	AB
A078110-006	AB
A078110-007	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 8 · 294 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
2026-08-18 06:07:40	2026-07	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 294 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078110-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078110-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078110-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078110-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-005	AB	1	`b8a1b40f171c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc920868-8845-b908-7ca8-0dee3e345af5	Product name	2	20230123
e24bc1b4-1e16-908e-3d09-29da3ca2fb1f	Product name	2	20170517

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43353-194-09	2020-01-31	C162847	48780-1	9d75b9d0-99a6-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ropinirole hydrochloride tablets safely and effectively. See full prescribing information for ropinirole hydrochloride tablets. ROPINIROLE Hydrochloride Tablets, USP, film coated for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-194-09	ropinirole hydrochloride	9000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	9000		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-194-09	EA - Each	43353-194	0ebf1d4f-5acd-48f9-aa45-b1e6b4826f7c	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-194	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 1 package rows	20160714_70e6fca5-554e-48d4-9d11-9879009c4bd8.zip

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	A-S Medication Solutions	a97d5e2d-4a17-4d80-9216-1b0780199502	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Northwind Health Company, LLC	ab6d21b6-2584-4b97-e053-2a95a90adc50	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	SOLCO HEALTHCARE US, LLC	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	SOLCO HEALTHCARE US, LLC	5823b3a2-3256-4d94-97b4-ec6b940312f4	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	AvPAK	e699a31a-25fc-554b-e053-2a95a90a843a	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	American Health Packaging	6849b3c0-e36b-4bea-82f2-b33ae3d44c95	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	6c10444a-48da-469d-bf8f-1e6e0b7e15f8	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Proficient Rx LP	89e3865c-1fe1-4f29-9606-8830df4bbe53	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	A-S Medication Solutions	9c4dacc6-cebc-4f42-85fc-41083512b290	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D7ZD41RZI9	ROPINIROLE HYDROCHLORIDE	91374-20-8	ROPINIROLE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312845	rOPINIRole HCl 0.25 MG Oral Tablet	PSN	70e6fca5-554e-48d4-9d11-9879009c4bd8	1
312846	rOPINIRole HCl 0.5 MG Oral Tablet	PSN	70e6fca5-554e-48d4-9d11-9879009c4bd8	1
314208	rOPINIRole HCl 1 MG Oral Tablet	PSN	70e6fca5-554e-48d4-9d11-9879009c4bd8	1
312847	rOPINIRole HCl 2 MG Oral Tablet	PSN	70e6fca5-554e-48d4-9d11-9879009c4bd8	1
312845	ropinirole 0.25 MG Oral Tablet	SCD	70e6fca5-554e-48d4-9d11-9879009c4bd8	1
312846	ropinirole 0.5 MG Oral Tablet	SCD	70e6fca5-554e-48d4-9d11-9879009c4bd8	1
314208	ropinirole 1 MG Oral Tablet	SCD	70e6fca5-554e-48d4-9d11-9879009c4bd8	1
312847	ropinirole 2 MG Oral Tablet	SCD	70e6fca5-554e-48d4-9d11-9879009c4bd8	1
312845	ropinirole 0.25 MG (as ropinirole hydrochloride) Oral Tablet	SY	70e6fca5-554e-48d4-9d11-9879009c4bd8	1
312846	ropinirole 0.5 MG (as ropinirole hydrochloride) Oral Tablet	SY	70e6fca5-554e-48d4-9d11-9879009c4bd8	1
314208	ropinirole 1 MG (as ropinirole hydrochloride) Oral Tablet	SY	70e6fca5-554e-48d4-9d11-9879009c4bd8	1
312847	ropinirole 2 MG (as ropinirole hydrochloride) Oral Tablet	SY	70e6fca5-554e-48d4-9d11-9879009c4bd8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-194-09	43353019409	9000 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ropinirole hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2016-07-14	HUMAN PRESCRIPTION DRUG LABEL	1