ropinirole

Product NDC: 0781-5780
11-digit product format: 007815780
Labeler code: 0781
Product ID: 0781-5780_d3bd26df-86a8-405a-ba67-5702cd8e089d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ropinirole
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA201047
Marketing category: ANDA
Marketing start: 2012-09-01
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: 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0781-5780		D	Discontinued by firm	2026-10-12
excluded package	package	0781-5780	0781-5780-31	D	Discontinued by firm	2026-10-12
excluded package	package	0781-5780	0781-5780-92	D	Discontinued by firm	2026-10-12

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 · 33 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	0781-5780-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5780-92	`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	0781-5780-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5780-92	`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	0781-5780-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5780-92	`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	0781-5780-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5780-92	`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	0781-5780-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5780-92	`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	0781-5780-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5780-92	`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	0781-5780-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5780-92	`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	0781-5780-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5780-92	`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	0781-5780-31	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5780-92	`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	0781-5780-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-5780-92	`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	0781-5780-31	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0781-5780-92	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A201047-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06
A201047-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06
A201047-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06
A201047-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06
A201047-006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A201047-001	AB
A201047-003	AB
A201047-004	AB
A201047-005	AB
A201047-006	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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A201047-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201047-003	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201047-004	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201047-005	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201047-006	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201047-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201047-003	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201047-004	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201047-005	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201047-006	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201047-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201047-003	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201047-004	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201047-005	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201047-006	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201047-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201047-003	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201047-004	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201047-005	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201047-006	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201047-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201047-003	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201047-004	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201047-005	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201047-006	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201047-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201047-003	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201047-004	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201047-005	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201047-006	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201047-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201047-003	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201047-004	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201047-005	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201047-006	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201047-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201047-003	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201047-004	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201047-005	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201047-006	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-06	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A201047-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201047-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201047-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201047-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201047-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201047-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201047-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201047-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201047-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201047-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201047-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201047-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201047-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201047-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201047-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201047-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201047-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201047-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201047-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201047-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201047-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201047-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201047-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201047-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201047-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201047-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201047-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201047-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201047-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201047-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201047-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201047-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201047-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201047-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201047-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201047-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201047-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201047-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201047-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201047-006	AB	1	`03ed91905a0d…`

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
0781-5780-31	EA - Each	0781-5780	ebb9bea5-7ce1-424b-bda9-a1bbc671b747	1	2013-02-13
0781-5780-92	EA - Each	0781-5780	4f2dd4d4-7ffb-4117-847b-1e00dfa8c4a3	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ROPINIROLE HYDROCHLORIDE	ACTIVE INGREDIENT	D7ZD41RZI9	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
ROPINIROLE	ACTIVE MOIETY	030PYR8953	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]	3

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	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-5780-31	00781578031	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5780-31)	2012-09-01	0000-00-00	No	No	Current
0781-5780-92	00781578092	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5780-92)	2012-09-01	0000-00-00	No	No	Current