Ropinirole

Product NDC: 63629-7139
11-digit product format: 636297139
Labeler code: 63629
Product ID: 63629-7139_196ee634-84d6-4331-985d-009ea35d23c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rOPINIRole
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077852
Marketing category: ANDA
Marketing start: 2008-05-05
Marketing end: 0000-00-00
Substance: ROPINIROLE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	63629-7139		D	Discontinued by firm		2026-08-10
excluded package	package	63629-7139	63629-7139-1	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 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-7139-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-7139-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-7139-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-7139-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-7139-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-7139-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-7139-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-7139-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-7139-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-7139-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-7139-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-7139-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-7139-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077852-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05
A077852-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05
A077852-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05
A077852-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05
A077852-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05
A077852-006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05
A077852-007	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 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077852-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077852-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077852-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077852-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077852-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077852-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077852-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077852-001	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	A077852-002	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	A077852-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077852-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077852-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077852-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077852-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077852-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077852-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077852-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077852-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077852-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077852-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077852-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077852-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077852-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077852-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077852-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077852-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077852-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077852-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077852-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077852-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077852-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077852-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077852-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077852-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077852-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2008-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077852-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	2008-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077852-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	2008-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077852-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	2008-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077852-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	2008-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077852-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	2008-05-05	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077852-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077852-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077852-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077852-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077852-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077852-006	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077852-007	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077852-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077852-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077852-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077852-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077852-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077852-006	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077852-007	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077852-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077852-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077852-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077852-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077852-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077852-006	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077852-007	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077852-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077852-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077852-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077852-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077852-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077852-006	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077852-007	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-7139-1	2020-10-16	C162847	48780-1	9d75b9d0-562f-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997
63629-7139-1	2020-01-31	C162847	48780-1	9d75b9d0-562f-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997

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
63629-7139-1	63629713901	30 TABLET in 1 BOTTLE (63629-7139-1)	30 tablet	2016-11-17	0000-00-00	No	No	Current