ROPINIROLE

Product NDC: 72189-222
Requested package NDC: 72189-222-30
11-digit product format: 721890222
Labeler code: 72189
Product ID: 72189-222_2c28281e-fe37-b7e4-e063-6294a90ad4f7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ROPINIROLE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA204022
Marketing category: ANDA
Marketing start: 2021-05-20
Substance: ROPINIROLE HYDROCHLORIDE
Active strength: 1 mg/1
Pharmacologic classes: Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-222	72189-222-30	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-222	72189-222-30	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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	TE codes	Approval date
A204022-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2017-02-28
A204022-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-02-28
A204022-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-28
A204022-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-28
A204022-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2017-02-28
A204022-006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-28
A204022-007	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2017-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204022-001	AB
A204022-002	AB
A204022-003	AB
A204022-004	AB
A204022-005	AB
A204022-006	AB
A204022-007	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 · 287 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	A204022-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2017-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204022-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204022-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204022-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204022-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2017-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204022-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204022-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2017-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204022-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2017-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204022-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204022-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204022-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204022-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2017-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204022-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204022-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2017-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204022-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2017-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204022-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204022-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204022-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204022-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2017-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204022-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204022-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2017-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204022-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2017-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204022-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204022-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204022-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204022-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2017-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204022-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204022-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2017-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204022-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2017-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204022-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204022-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204022-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204022-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2017-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204022-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2017-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204022-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2017-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204022-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2017-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204022-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204022-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2017-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204022-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2017-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204022-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2017-02-28	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 287 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	A204022-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204022-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204022-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204022-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204022-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204022-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204022-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204022-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204022-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204022-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204022-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204022-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204022-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204022-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204022-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204022-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204022-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204022-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204022-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204022-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204022-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204022-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204022-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204022-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204022-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204022-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204022-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204022-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204022-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204022-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204022-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204022-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204022-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204022-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204022-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204022-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204022-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204022-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204022-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204022-005	AB	1	`03ed91905a0d…`

Additional Listing Data#

Finished product: Yes
Brand name base: ROPINIROLE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ROPINIROLE HYDROCHLORIDE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
D7ZD41RZI9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314208	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c2c38b4c-b139-45f2-e053-2995a90a262c	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-222-30	ROPINIROLE	30 in 1 BOTTLE	TABLET, FILM COATED	30		3
72189-222-60	ROPINIROLE	60 in 1 BOTTLE	TABLET, FILM COATED	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-222-30	EA - Each	72189-222	1d8b8770-10a8-4fa6-b0e4-ff949053bcbc	1	2022-01-06
72189-222-60	EA - Each	72189-222	308448a2-b950-47a4-ae4e-80ebe12ce003	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-222	ROPINIROLE TABLET, FILM COATED [DIRECT RX]	3	Current NDC, Legacy NDC, 2 package rows	20250121_c2c38b4c-b139-45f2-e053-2995a90a262c.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ropinirole	ROPINIROLE	Direct_Rx	e1fb0b51-4f8a-965d-e053-2a95a90ad936	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204022 application number: ANDA204022
ROPINIROLE	ROPINIROLE	DIRECT RX	c2c38b4c-b139-45f2-e053-2995a90a262c	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204022 application number: ANDA204022 ndc (package): 72189-222-30 ndc (product): 72189-222 ndc11 (package): 72189022230
ropinirole	ROPINIROLE	Bryant Ranch Prepack	8ebaa083-9f72-4e43-a4c4-36e3e7b5d5f2	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204022 application number: ANDA204022
ropinirole	ROPINIROLE	Bryant Ranch Prepack	ceb3a0cb-8677-4acd-8313-5498201e81d9	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204022 application number: ANDA204022
ropinirole	ROPINIROLE	Bryant Ranch Prepack	cb378fb5-6dca-43e9-83bc-3c54eb9c1af7	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204022 application number: ANDA204022
ropinirole	ROPINIROLE	Bryant Ranch Prepack	55bb5cf4-0e12-41b0-bc52-50b26fe408de	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204022 application number: ANDA204022
ropinirole	ROPINIROLE	Accord Healthcare Inc.	4a2a5b63-5b14-6975-e054-00144ff8d46c	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204022 application number: ANDA204022
ropinirole	ROPINIROLE	A-S Medication Solutions	4f4729f8-c910-4a09-a4b4-b4243e7f0105	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204022 application number: ANDA204022

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314208	rOPINIRole HCl 1 MG Oral Tablet	PSN	c2c38b4c-b139-45f2-e053-2995a90a262c	3
314208	ropinirole 1 MG Oral Tablet	SCD	c2c38b4c-b139-45f2-e053-2995a90a262c	3
314208	ropinirole 1 MG (as ropinirole hydrochloride) Oral Tablet	SY	c2c38b4c-b139-45f2-e053-2995a90a262c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-222-30	72189022230	30 TABLET, FILM COATED in 1 BOTTLE (72189-222-30)	2021-05-20	0000-00-00	No	No	Current