ROPINIROLE

Product NDC: 55154-7633
11-digit product format: 551547633
Labeler code: 55154
Product ID: 55154-7633_82ee8a91-c8ae-4ba4-a215-78bc057f0788
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ROPINIROLE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA090429
Marketing category: ANDA
Marketing start: 2014-10-01
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

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
A090429-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-03-24
A090429-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-03-24
A090429-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-03-24
A090429-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-03-24
A090429-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-03-24
A090429-006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-03-24
A090429-007	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090429-001	AB
A090429-002	AB
A090429-003	AB
A090429-004	AB
A090429-005	AB
A090429-006	AB
A090429-007	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	A090429-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090429-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-03-24	`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	A090429-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090429-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090429-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090429-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090429-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090429-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090429-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090429-005	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	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312845	Internal RxNorm lookup
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
7bf874a3-4d45-41ab-9796-6729f409031c	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
55154-7633-0	ROPINIROLE	10 in 1 BAG	TABLET, FILM COATED	10		8
55154-7633-0	ROPINIROLE	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-7633	ROPINIROLE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]	7	Current NDC, Legacy NDC, 2 package rows	20250427_7bf874a3-4d45-41ab-9796-6729f409031c.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ROPINIROLE	ROPINIROLE	Cardinal Health 107, LLC	7bf874a3-4d45-41ab-9796-6729f409031c	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429 ndc (product): 55154-7633
ROPINIROLE	ROPINIROLE	Major Pharmaceuticals	e7ef58c0-73ba-4af2-b82b-a33954ec44df	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429
ROPINIROLE	ROPINIROLE	Alembic Pharmaceuticals Limited	9a25f575-09ab-4d32-b73e-5426f08c00c4	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429
ROPINIROLE	ROPINIROLE	Alembic Pharmaceuticals Inc.	6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	3b8bb729-e084-4d45-9774-63cae192be32	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429
ROPINIROLE	ROPINIROLE	Coupler LLC	2cd9b1e8-5856-4b79-e063-6394a90ab260	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429
ROPINIROLE	ROPINIROLE	Coupler LLC	2cdae415-479b-c14c-e063-6394a90adb6c	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	48a63d7e-c0af-4b09-863c-2af7beb2e80f	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	00c0ab77-914a-4e8a-bcb7-24cecacfebb1	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090429 application number: ANDA090429

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	7bf874a3-4d45-41ab-9796-6729f409031c	8
314208	rOPINIRole HCl 1 MG Oral Tablet	PSN	7bf874a3-4d45-41ab-9796-6729f409031c	8
312845	ropinirole 0.25 MG Oral Tablet	SCD	7bf874a3-4d45-41ab-9796-6729f409031c	8
314208	ropinirole 1 MG Oral Tablet	SCD	7bf874a3-4d45-41ab-9796-6729f409031c	8
312845	ropinirole 0.25 MG (as ropinirole hydrochloride) Oral Tablet	SY	7bf874a3-4d45-41ab-9796-6729f409031c	8
314208	ropinirole 1 MG (as ropinirole hydrochloride) Oral Tablet	SY	7bf874a3-4d45-41ab-9796-6729f409031c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-7633-0	55154763300	10 BLISTER PACK in 1 BAG (55154-7633-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2014-10-01	0000-00-00	No	No	Current