ROPINIROLE

Product NDC: 43547-555
11-digit product format: 435470555
Labeler code: 43547
Product ID: 43547-555_9bbec058-00a5-4353-bd58-426ddb0b2020
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ropinirole
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Solco Healthcare US, LLC
Application: ANDA204413
Marketing category: ANDA
Marketing start: 2022-03-22
Substance: ROPINIROLE
Active strength: 4 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
A204413-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11
A204413-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11
A204413-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11
A204413-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11
A204413-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204413-001	AB
A204413-002	AB
A204413-003	AB
A204413-004	AB
A204413-005	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 4 · 145 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	A204413-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204413-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204413-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204413-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204413-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204413-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204413-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204413-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204413-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204413-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204413-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204413-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204413-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204413-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204413-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204413-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204413-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204413-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204413-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204413-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204413-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204413-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204413-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204413-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204413-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204413-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204413-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204413-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204413-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204413-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204413-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204413-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204413-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204413-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204413-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204413-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204413-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204413-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204413-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204413-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2022-05-11	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 145 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	A204413-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204413-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204413-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204413-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204413-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204413-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204413-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204413-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204413-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204413-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204413-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204413-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204413-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204413-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204413-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204413-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204413-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204413-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204413-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204413-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204413-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204413-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204413-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204413-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204413-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204413-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204413-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204413-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204413-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204413-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204413-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204413-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204413-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204413-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204413-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204413-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204413-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204413-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204413-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204413-005	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	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
030PYR8953	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
213dd2f4-4a71-456c-b3c7-b709c7bd7445	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
dc920868-8845-b908-7ca8-0dee3e345af5	Product name	2	20230123
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
e24bc1b4-1e16-908e-3d09-29da3ca2fb1f	Product name	2	20170517
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43547-555-03	ROPINIROLE	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		6
43547-555-09	ROPINIROLE	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-555-03	EA - Each	43547-555	819afd63-2355-4f37-9dd3-2bdd87841bb5	1	2022-09-12
43547-555-09	EA - Each	43547-555	7621ef8a-d638-4d7a-8e20-62a1ed1009e1	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-555	ROPINIROLE TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240817_213dd2f4-4a71-456c-b3c7-b709c7bd7445.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ROPINIROLE	ROPINIROLE	Solco Healthcare US, LLC	213dd2f4-4a71-456c-b3c7-b709c7bd7445	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204413 application number: ANDA204413 ndc (product): 43547-555

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
799055	rOPINIRole 2 MG 24HR Extended Release Oral Tablet	PSN	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
799056	rOPINIRole 4 MG 24HR Extended Release Oral Tablet	PSN	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
848582	rOPINIRole 6 MG 24HR Extended Release Oral Tablet	PSN	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
799054	rOPINIRole 8 MG 24HR Extended Release Oral Tablet	PSN	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
824959	24 HR ropinirole 12 MG Extended Release Oral Tablet	SCD	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
799055	24 HR ropinirole 2 MG Extended Release Oral Tablet	SCD	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
799056	24 HR ropinirole 4 MG Extended Release Oral Tablet	SCD	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
848582	24 HR ropinirole 6 MG Extended Release Oral Tablet	SCD	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
799054	24 HR ropinirole 8 MG Extended Release Oral Tablet	SCD	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
824959	ropinirole 12 MG (as ropinirole hydrochloride 13.68 MG) 24 HR Extended Release Oral Tablet	SY	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
824959	ropinirole 12 MG 24 HR Extended Release Oral Tablet	SY	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
799055	ropinirole 2 MG (as ropinirole hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet	SY	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
799055	ropinirole 2 MG 24 HR Extended Release Oral Tablet	SY	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
799056	ropinirole 4 MG (as ropinirole hydrochloride 4.56 MG) 24 HR Extended Release Oral Tablet	SY	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
799056	ropinirole 4 MG 24 HR Extended Release Oral Tablet	SY	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
848582	ropinirole 6 MG (ropinirole hydrochloride 6.84 MG) 24 HR Extended Release Oral Tablet	SY	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
848582	ropinirole 6 MG 24 HR Extended Release Oral Tablet	SY	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
799054	ropinirole 8 MG (as ropinirole hydrochloride 9.12 MG) 24 HR Extended Release Oral Tablet	SY	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6
799054	ropinirole 8 MG 24 HR Extended Release Oral Tablet	SY	213dd2f4-4a71-456c-b3c7-b709c7bd7445	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-555-03	43547055503	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-555-03)	2022-03-22	0000-00-00	No	No	Current
43547-555-09	43547055509	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-555-09)	2022-03-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ROPINIROLE	Solco Healthcare US, LLC \| Prinston Pharmaceutical Inc. \| Zhejiang Huahai Pharmaceutical Co., LTD	2025-05-23	HUMAN PRESCRIPTION DRUG LABEL	6