Ropinirole

Product NDC: 69452-361
11-digit product format: 694520361
Labeler code: 69452
Product ID: 69452-361_4fb684db-c9c7-f5a9-e063-6394a90a0931
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ropinirole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA079229
Marketing category: ANDA
Marketing start: 2022-09-15
Substance: ROPINIROLE HYDROCHLORIDE
Active strength: 4 mg/1
Pharmacologic classes: Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A079229-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2012-11-28
A079229-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2012-11-28
A079229-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2012-11-28
A079229-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28
A079229-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2012-11-28
A079229-006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28
A079229-007	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2012-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079229-001	AB
A079229-002	AB
A079229-003	AB
A079229-004	AB
A079229-005	AB
A079229-006	AB
A079229-007	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	A079229-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2012-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079229-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2012-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079229-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2012-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079229-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079229-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2012-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079229-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079229-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2012-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079229-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2012-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079229-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2012-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079229-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2012-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079229-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079229-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2012-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079229-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079229-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2012-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079229-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2012-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079229-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2012-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079229-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2012-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079229-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079229-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2012-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079229-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079229-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2012-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079229-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2012-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079229-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2012-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079229-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2012-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079229-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079229-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2012-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079229-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079229-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2012-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079229-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2012-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079229-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2012-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079229-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2012-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079229-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079229-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2012-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079229-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2012-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079229-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2012-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079229-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2012-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079229-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2012-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079229-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2012-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079229-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2012-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079229-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2012-11-28	`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	A079229-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079229-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079229-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079229-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079229-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079229-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079229-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079229-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079229-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079229-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079229-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079229-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079229-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079229-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079229-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079229-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079229-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079229-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079229-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079229-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079229-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079229-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079229-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079229-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079229-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079229-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079229-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079229-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079229-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079229-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079229-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079229-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079229-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079229-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079229-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079229-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079229-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079229-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079229-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079229-005	AB	1	`03ed91905a0d…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ropinirole
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ROPINIROLE HYDROCHLORIDE	4 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 · 7 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283858	Internal RxNorm lookup
312845	Internal RxNorm lookup
312846	Internal RxNorm lookup
312847	Internal RxNorm lookup
312849	Internal RxNorm lookup
314208	Internal RxNorm lookup
562704	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
4e6b070c-50a6-4742-af3c-59b45c45735e	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
69452-361-20	Ropinirole	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-361-20	EA - Each	69452-361	0733934f-aea2-49e5-b371-ccd0d979482b	1	2023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-361	ROPINIROLE TABLET, FILM COATED [BIONPHARMA INC.]	3	Current NDC, Legacy NDC, 1 package rows	20231211_4e6b070c-50a6-4742-af3c-59b45c45735e.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ropinirole	ROPINIROLE	Bryant Ranch Prepack	e9ba4108-7095-4771-840e-bf1e08b5f4da	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079229 application number: ANDA079229
Ropinirole	ROPINIROLE	Bryant Ranch Prepack	eaca095f-198b-4c00-812b-1777bf2fc6a9	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079229 application number: ANDA079229
Ropinirole	ROPINIROLE	Bryant Ranch Prepack	391a1566-09b5-4362-9fbd-5afe4803269f	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079229 application number: ANDA079229
Ropinirole	ROPINIROLE	Bryant Ranch Prepack	af340f28-92b2-49af-b651-b9b01ca3ce6c	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079229 application number: ANDA079229
Ropinirole	ROPINIROLE	ASCLEMED USA INC.	8f3612f0-0976-4de7-a1d6-eabaa8b75f9c	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079229 application number: ANDA079229
Ropinirole	ROPINIROLE	Bionpharma Inc.	4e6b070c-50a6-4742-af3c-59b45c45735e	2026-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079229 application number: ANDA079229 ndc (product): 69452-361
Ropinirole	ROPINIROLE	Bryant Ranch Prepack	245fc49d-609e-4431-b8fa-668b39d12ec2	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079229 application number: ANDA079229
Ropinirole	ROPINIROLE	REMEDYREPACK INC.	cdc63b7a-062a-4519-a63e-e48a356f641c	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079229 application number: ANDA079229
Ropinirole	ROPINIROLE	Direct_Rx	febd4b37-6039-5522-e053-6394a90a855f	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079229 application number: ANDA079229
Ropinirole	ROPINIROLE	A-S Medication Solutions	339a961e-4eb0-4406-913e-ccc9e9bde084	2024-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079229 application number: ANDA079229

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
312845	rOPINIRole HCl 0.25 MG Oral Tablet	PSN	4e6b070c-50a6-4742-af3c-59b45c45735e	6
312846	rOPINIRole HCl 0.5 MG Oral Tablet	PSN	4e6b070c-50a6-4742-af3c-59b45c45735e	6
314208	rOPINIRole HCl 1 MG Oral Tablet	PSN	4e6b070c-50a6-4742-af3c-59b45c45735e	6
312847	rOPINIRole HCl 2 MG Oral Tablet	PSN	4e6b070c-50a6-4742-af3c-59b45c45735e	6
283858	rOPINIRole HCl 3 MG Oral Tablet	PSN	4e6b070c-50a6-4742-af3c-59b45c45735e	6
562704	rOPINIRole HCl 4 MG Oral Tablet	PSN	4e6b070c-50a6-4742-af3c-59b45c45735e	6
312849	rOPINIRole HCl 5 MG Oral Tablet	PSN	4e6b070c-50a6-4742-af3c-59b45c45735e	6
312845	ropinirole 0.25 MG Oral Tablet	SCD	4e6b070c-50a6-4742-af3c-59b45c45735e	6
312846	ropinirole 0.5 MG Oral Tablet	SCD	4e6b070c-50a6-4742-af3c-59b45c45735e	6
314208	ropinirole 1 MG Oral Tablet	SCD	4e6b070c-50a6-4742-af3c-59b45c45735e	6
312847	ropinirole 2 MG Oral Tablet	SCD	4e6b070c-50a6-4742-af3c-59b45c45735e	6
283858	ropinirole 3 MG Oral Tablet	SCD	4e6b070c-50a6-4742-af3c-59b45c45735e	6
562704	ropinirole 4 MG Oral Tablet	SCD	4e6b070c-50a6-4742-af3c-59b45c45735e	6
312849	ropinirole 5 MG Oral Tablet	SCD	4e6b070c-50a6-4742-af3c-59b45c45735e	6
312845	ropinirole 0.25 MG (as ropinirole hydrochloride) Oral Tablet	SY	4e6b070c-50a6-4742-af3c-59b45c45735e	6
312846	ropinirole 0.5 MG (as ropinirole hydrochloride) Oral Tablet	SY	4e6b070c-50a6-4742-af3c-59b45c45735e	6
314208	ropinirole 1 MG (as ropinirole hydrochloride) Oral Tablet	SY	4e6b070c-50a6-4742-af3c-59b45c45735e	6
312847	ropinirole 2 MG (as ropinirole hydrochloride) Oral Tablet	SY	4e6b070c-50a6-4742-af3c-59b45c45735e	6
283858	ropinirole 3 MG (as ropinirole hydrochloride) Oral Tablet	SY	4e6b070c-50a6-4742-af3c-59b45c45735e	6
562704	ropinirole 4 MG (as ropinirole hydrochloride) Oral Tablet	SY	4e6b070c-50a6-4742-af3c-59b45c45735e	6
312849	ropinirole 5 MG (as ropinirole hydrochloride) Oral Tablet	SY	4e6b070c-50a6-4742-af3c-59b45c45735e	6
562704	rOPINIRole HCl 4 MG Oral Tablet	PSN	339a961e-4eb0-4406-913e-ccc9e9bde084	1
562704	ropinirole 4 MG Oral Tablet	SCD	339a961e-4eb0-4406-913e-ccc9e9bde084	1
562704	ropinirole 4 MG (as ropinirole hydrochloride) Oral Tablet	SY	339a961e-4eb0-4406-913e-ccc9e9bde084	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69452-361-20	69452036120	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-361-20)	2022-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ropinirole	Bionpharma Inc. \| Optimus Pharma Private Limited \| OrBion Pharmaceuticals Private Limited	2026-04-18	HUMAN PRESCRIPTION DRUG LABEL	6
Ropinirole	A-S Medication Solutions	2024-11-08	HUMAN PRESCRIPTION DRUG LABEL	1