Ropinirole Hydrochloride

Product NDC: 64679-774
11-digit product format: 646790774
Labeler code: 64679
Product ID: 64679-774_16dc7f02-9997-458e-b829-105cacbcbeab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ropinirole Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Wockhardt USA LLC.
Application: ANDA091395
Marketing category: ANDA
Marketing start: 2012-08-15
Marketing end: 0000-00-00
Substance: ROPINIROLE HYDROCHLORIDE
Active strength: 8 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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64679-774		D	Discontinued by firm	2026-08-07
excluded package	package	64679-774	64679-774-01	D	Discontinued by firm	2026-08-07
excluded package	package	64679-774	64679-774-02	D	Discontinued by firm	2026-08-07
excluded package	package	64679-774	64679-774-03	D	Discontinued by firm	2026-08-07
excluded package	package	64679-774	64679-774-04	D	Discontinued by firm	2026-08-07
excluded package	package	64679-774	64679-774-05	D	Discontinued by firm	2026-08-07

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 3 · 126 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	64679-774-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-774-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-774-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-774-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-774-03	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	64679-774-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-774-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-774-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-774-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-774-03	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	64679-774-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-774-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-774-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-774-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-774-03	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	64679-774-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-774-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-774-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-774-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-774-03	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	64679-774-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-774-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-774-05	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-774-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-774-03	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	64679-774-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-774-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-774-05	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-774-04	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-774-03	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	64679-774-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-774-02	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-774-05	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-774-04	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-774-03	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	64679-774-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-774-02	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-774-05	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-774-04	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-774-03	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	64679-774-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-774-02	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-774-05	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-774-04	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-774-03	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-774-02	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-774-04	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-774-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-774-05	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-774-03	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`

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

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
A091395-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27
A091395-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27
A091395-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27
A091395-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27
A091395-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091395-001	AB
A091395-002	AB
A091395-003	AB
A091395-004	AB
A091395-005	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 · 205 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
2026-02-19 14:30 UTC	2026-02	A091395-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091395-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091395-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091395-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091395-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091395-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091395-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091395-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091395-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091395-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091395-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091395-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091395-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091395-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091395-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091395-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091395-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091395-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091395-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091395-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091395-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091395-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091395-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091395-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091395-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091395-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091395-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091395-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091395-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091395-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091395-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091395-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091395-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091395-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091395-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091395-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091395-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091395-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091395-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091395-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-27	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091395-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091395-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091395-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091395-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091395-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091395-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091395-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091395-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091395-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091395-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091395-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091395-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091395-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091395-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091395-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091395-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091395-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091395-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091395-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091395-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091395-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091395-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091395-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091395-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091395-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091395-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091395-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091395-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091395-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091395-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091395-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091395-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091395-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091395-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091395-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091395-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091395-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091395-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091395-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091395-005	AB	1	`5bbf6a4d5a75…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64679-774-01	2024-11-15	These highlights do not include all the information needed to use ROPINIROLE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ROPINIROLE EXTENDED-RELEASE TABLETS. ROPINIROLE extended-release tablets, for oral use Initial U.S. Approval: 1997
64679-774-02	2024-11-15	These highlights do not include all the information needed to use ROPINIROLE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ROPINIROLE EXTENDED-RELEASE TABLETS. ROPINIROLE extended-release tablets, for oral use Initial U.S. Approval: 1997
64679-774-03	2024-11-15	These highlights do not include all the information needed to use ROPINIROLE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ROPINIROLE EXTENDED-RELEASE TABLETS. ROPINIROLE extended-release tablets, for oral use Initial U.S. Approval: 1997
64679-774-04	2024-11-15	These highlights do not include all the information needed to use ROPINIROLE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ROPINIROLE EXTENDED-RELEASE TABLETS. ROPINIROLE extended-release tablets, for oral use Initial U.S. Approval: 1997
64679-774-05	2024-11-15	These highlights do not include all the information needed to use ROPINIROLE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ROPINIROLE EXTENDED-RELEASE TABLETS. ROPINIROLE extended-release tablets, for oral use Initial U.S. Approval: 1997
64679-774-01	2020-01-31	These highlights do not include all the information needed to use ROPINIROLE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ROPINIROLE EXTENDED-RELEASE TABLETS. ROPINIROLE extended-release tablets, for oral use Initial U.S. Approval: 1997
64679-774-02	2020-01-31	These highlights do not include all the information needed to use ROPINIROLE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ROPINIROLE EXTENDED-RELEASE TABLETS. ROPINIROLE extended-release tablets, for oral use Initial U.S. Approval: 1997
64679-774-03	2020-01-31	These highlights do not include all the information needed to use ROPINIROLE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ROPINIROLE EXTENDED-RELEASE TABLETS. ROPINIROLE extended-release tablets, for oral use Initial U.S. Approval: 1997
64679-774-04	2020-01-31	These highlights do not include all the information needed to use ROPINIROLE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ROPINIROLE EXTENDED-RELEASE TABLETS. ROPINIROLE extended-release tablets, for oral use Initial U.S. Approval: 1997
64679-774-05	2020-01-31	These highlights do not include all the information needed to use ROPINIROLE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ROPINIROLE EXTENDED-RELEASE TABLETS. ROPINIROLE extended-release tablets, for oral use Initial U.S. Approval: 1997

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ROPINIROLE HYDROCHLORIDE	ACTIVE INGREDIENT	D7ZD41RZI9	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
ROPINIROLE	ACTIVE MOIETY	030PYR8953	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ropinirole Hydrochloride	Wockhardt USA LLC. \| Wockhardt Limited	2018-03-22	HUMAN PRESCRIPTION DRUG LABEL	4