Ropinirole

Product NDC: 0228-3658
11-digit product format: 002283658
Labeler code: 0228
Product ID: 0228-3658_3499549d-d3ad-4636-8234-2539c0fbfac1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ropinirole
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA090869
Marketing category: ANDA
Marketing start: 2012-08-23
Substance: ROPINIROLE HYDROCHLORIDE
Active strength: 2 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

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
A090869-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17
A090869-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17
A090869-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17
A090869-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17
A090869-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090869-001	AB
A090869-002	AB
A090869-003	AB
A090869-004	AB
A090869-005	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	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-17	`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	A090869-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090869-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090869-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090869-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090869-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090869-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090869-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090869-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090869-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090869-005	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ROPINIROLE HYDROCHLORIDE	2 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
799054	Internal RxNorm lookup
799055	Internal RxNorm lookup
799056	Internal RxNorm lookup
824959	Internal RxNorm lookup
848582	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
300946bf-2f83-471d-868d-9820b65c52bb	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
0228-3658-03	Ropinirole	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		20
0228-3658-09	Ropinirole	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0228-3658-03	EA - Each	0228-3658	d819f72c-4e36-4143-955c-d9aa1250780f	1	2012-07-24
0228-3658-09	EA - Each	0228-3658	f476e81a-0fd7-477c-be41-972ade61853e	1	2012-07-24

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 [ACTAVIS PHARMA, INC.]	9
ROPINIROLE	ACTIVE MOIETY	030PYR8953	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
ROPINIROLE HYDROCHLORIDE	ACTIVE INGREDIENT	D7ZD41RZI9	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
ROPINIROLE	ACTIVE MOIETY	030PYR8953	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Castor Oil	INACTIVE INGREDIENT	D5340Y2I9G	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Fd&c Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Fd&c Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Ferrosoferric Oxide	INACTIVE INGREDIENT	XM0M87F357	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Polyvinyl Alcohol	INACTIVE INGREDIENT	532B59J990	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1
Triacetin	INACTIVE INGREDIENT	XHX3C3X673	ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0228-3658	ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	19	Current NDC, Legacy NDC, 2 package rows	20241105_300946bf-2f83-471d-868d-9820b65c52bb.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	AvKARE	abd344d9-7635-62a2-d4e1-38fc46937397	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090869 application number: ANDA090869
Ropinirole	ROPINIROLE	Actavis Pharma, Inc.	300946bf-2f83-471d-868d-9820b65c52bb	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090869 application number: ANDA090869 ndc (product): 0228-3658

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
824959	rOPINIRole 12 MG 24HR Extended Release Oral Tablet	PSN	300946bf-2f83-471d-868d-9820b65c52bb	20
799055	rOPINIRole 2 MG 24HR Extended Release Oral Tablet	PSN	300946bf-2f83-471d-868d-9820b65c52bb	20
799056	rOPINIRole 4 MG 24HR Extended Release Oral Tablet	PSN	300946bf-2f83-471d-868d-9820b65c52bb	20
848582	rOPINIRole 6 MG 24HR Extended Release Oral Tablet	PSN	300946bf-2f83-471d-868d-9820b65c52bb	20
799054	rOPINIRole 8 MG 24HR Extended Release Oral Tablet	PSN	300946bf-2f83-471d-868d-9820b65c52bb	20
824959	24 HR ropinirole 12 MG Extended Release Oral Tablet	SCD	300946bf-2f83-471d-868d-9820b65c52bb	20
799055	24 HR ropinirole 2 MG Extended Release Oral Tablet	SCD	300946bf-2f83-471d-868d-9820b65c52bb	20
799056	24 HR ropinirole 4 MG Extended Release Oral Tablet	SCD	300946bf-2f83-471d-868d-9820b65c52bb	20
848582	24 HR ropinirole 6 MG Extended Release Oral Tablet	SCD	300946bf-2f83-471d-868d-9820b65c52bb	20
799054	24 HR ropinirole 8 MG Extended Release Oral Tablet	SCD	300946bf-2f83-471d-868d-9820b65c52bb	20
824959	ropinirole 12 MG (as ropinirole hydrochloride 13.68 MG) 24 HR Extended Release Oral Tablet	SY	300946bf-2f83-471d-868d-9820b65c52bb	20
824959	ropinirole 12 MG 24 HR Extended Release Oral Tablet	SY	300946bf-2f83-471d-868d-9820b65c52bb	20
799055	ropinirole 2 MG (as ropinirole hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet	SY	300946bf-2f83-471d-868d-9820b65c52bb	20
799055	ropinirole 2 MG 24 HR Extended Release Oral Tablet	SY	300946bf-2f83-471d-868d-9820b65c52bb	20
799056	ropinirole 4 MG (as ropinirole hydrochloride 4.56 MG) 24 HR Extended Release Oral Tablet	SY	300946bf-2f83-471d-868d-9820b65c52bb	20
799056	ropinirole 4 MG 24 HR Extended Release Oral Tablet	SY	300946bf-2f83-471d-868d-9820b65c52bb	20
848582	ropinirole 6 MG (ropinirole hydrochloride 6.84 MG) 24 HR Extended Release Oral Tablet	SY	300946bf-2f83-471d-868d-9820b65c52bb	20
848582	ropinirole 6 MG 24 HR Extended Release Oral Tablet	SY	300946bf-2f83-471d-868d-9820b65c52bb	20
799054	ropinirole 8 MG (as ropinirole hydrochloride 9.12 MG) 24 HR Extended Release Oral Tablet	SY	300946bf-2f83-471d-868d-9820b65c52bb	20
799054	ropinirole 8 MG 24 HR Extended Release Oral Tablet	SY	300946bf-2f83-471d-868d-9820b65c52bb	20
824959	rOPINIRole 12 MG 24HR Extended Release Oral Tablet	PSN	abd344d9-7635-62a2-d4e1-38fc46937397	6
799055	rOPINIRole 2 MG 24HR Extended Release Oral Tablet	PSN	abd344d9-7635-62a2-d4e1-38fc46937397	6
799056	rOPINIRole 4 MG 24HR Extended Release Oral Tablet	PSN	abd344d9-7635-62a2-d4e1-38fc46937397	6
848582	rOPINIRole 6 MG 24HR Extended Release Oral Tablet	PSN	abd344d9-7635-62a2-d4e1-38fc46937397	6
799054	rOPINIRole 8 MG 24HR Extended Release Oral Tablet	PSN	abd344d9-7635-62a2-d4e1-38fc46937397	6
824959	24 HR ropinirole 12 MG Extended Release Oral Tablet	SCD	abd344d9-7635-62a2-d4e1-38fc46937397	6
799055	24 HR ropinirole 2 MG Extended Release Oral Tablet	SCD	abd344d9-7635-62a2-d4e1-38fc46937397	6
799056	24 HR ropinirole 4 MG Extended Release Oral Tablet	SCD	abd344d9-7635-62a2-d4e1-38fc46937397	6
848582	24 HR ropinirole 6 MG Extended Release Oral Tablet	SCD	abd344d9-7635-62a2-d4e1-38fc46937397	6
799054	24 HR ropinirole 8 MG Extended Release Oral Tablet	SCD	abd344d9-7635-62a2-d4e1-38fc46937397	6
824959	ropinirole 12 MG (as ropinirole hydrochloride 13.68 MG) 24 HR Extended Release Oral Tablet	SY	abd344d9-7635-62a2-d4e1-38fc46937397	6
824959	ropinirole 12 MG 24 HR Extended Release Oral Tablet	SY	abd344d9-7635-62a2-d4e1-38fc46937397	6
799055	ropinirole 2 MG (as ropinirole hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet	SY	abd344d9-7635-62a2-d4e1-38fc46937397	6
799055	ropinirole 2 MG 24 HR Extended Release Oral Tablet	SY	abd344d9-7635-62a2-d4e1-38fc46937397	6
799056	ropinirole 4 MG (as ropinirole hydrochloride 4.56 MG) 24 HR Extended Release Oral Tablet	SY	abd344d9-7635-62a2-d4e1-38fc46937397	6
799056	ropinirole 4 MG 24 HR Extended Release Oral Tablet	SY	abd344d9-7635-62a2-d4e1-38fc46937397	6
848582	ropinirole 6 MG (ropinirole hydrochloride 6.84 MG) 24 HR Extended Release Oral Tablet	SY	abd344d9-7635-62a2-d4e1-38fc46937397	6
848582	ropinirole 6 MG 24 HR Extended Release Oral Tablet	SY	abd344d9-7635-62a2-d4e1-38fc46937397	6
799054	ropinirole 8 MG (as ropinirole hydrochloride 9.12 MG) 24 HR Extended Release Oral Tablet	SY	abd344d9-7635-62a2-d4e1-38fc46937397	6
799054	ropinirole 8 MG 24 HR Extended Release Oral Tablet	SY	abd344d9-7635-62a2-d4e1-38fc46937397	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0228-3658-03	00228365803	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3658-03)	2012-08-23	0000-00-00	No	No	Current
0228-3658-09	00228365809	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3658-09)	2012-08-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ROPINIROLE HYDROCHLORIDE	AvKARE	2025-01-09	HUMAN PRESCRIPTION DRUG LABEL	6
Ropinirole	Actavis Pharma, Inc.	2023-08-01	HUMAN PRESCRIPTION DRUG LABEL	20