Ropinirole Hydrochloride

Product NDC: 43353-258
11-digit product format: 433530258
Labeler code: 43353
Product ID: 43353-258_137b8563-7235-4e5b-bcdf-68e788eb8d8b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ropinirole
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA078881
Marketing category: ANDA
Marketing start: 2016-06-20
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: 2020-12-31
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	43353-258		D	Discontinued by firm		2026-10-15
excluded package	package	43353-258	43353-258-09	D	Discontinued by firm		2026-10-15

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 · 4 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	43353-258-09	`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	43353-258-09	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A078881-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05
A078881-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05
A078881-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05
A078881-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05
A078881-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05
A078881-006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05
A078881-007	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19

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 · 308 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078881-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078881-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078881-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078881-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078881-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078881-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078881-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078881-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078881-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078881-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078881-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078881-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078881-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078881-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078881-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078881-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078881-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078881-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078881-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078881-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078881-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078881-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078881-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078881-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078881-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078881-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078881-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078881-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078881-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078881-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078881-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078881-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078881-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078881-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078881-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078881-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078881-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078881-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078881-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078881-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A078881-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078881-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078881-006	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078881-007	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078881-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078881-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078881-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078881-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078881-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078881-006	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078881-007	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A078881-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078881-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078881-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078881-004	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078881-005	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078881-006	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078881-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078881-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078881-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078881-004	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078881-005	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078881-006	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078881-007	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078881-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078881-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078881-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078881-004	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078881-005	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078881-006	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078881-007	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078881-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078881-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078881-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078881-004	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078881-005	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078881-006	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078881-007	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078881-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A078881-002	AB	1	`e64feba35796…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-258-09	EA - Each	43353-258	c4de868d-f031-4703-87b8-40192559648b	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-258	ROPINIROLE HYDROCHLORIDE (ROPINIROLE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20171005_471a4163-9b09-425c-8736-961d26ab11c3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D7ZD41RZI9	ROPINIROLE HYDROCHLORIDE	91374-20-8	ROPINIROLE HYDROCHLORIDE
030PYR8953	ROPINIROLE	91374-21-9	ropinirole

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-258-09	43353025809	9000 TABLET in 1 BOTTLE, PLASTIC (43353-258-09)	9000 tablet	2016-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ropinirole Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2017-10-04	HUMAN PRESCRIPTION DRUG LABEL	1