ropinirole

Product NDC: 68462-259
11-digit product format: 684620259
Labeler code: 68462
Product ID: 68462-259_eaf797e1-337e-4fc1-bb49-29227b544fdb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ropinirole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA090135
Marketing category: ANDA
Marketing start: 2010-02-25
Substance: ROPINIROLE HYDROCHLORIDE
Active strength: 5 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
A090135-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-02-25
A090135-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-02-25
A090135-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-02-25
A090135-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-02-25
A090135-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-02-25
A090135-006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-02-25
A090135-007	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090135-001	AB
A090135-002	AB
A090135-003	AB
A090135-004	AB
A090135-005	AB
A090135-006	AB
A090135-007	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	A090135-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090135-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090135-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090135-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090135-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090135-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090135-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090135-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090135-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090135-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090135-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090135-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090135-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090135-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090135-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090135-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090135-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090135-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090135-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090135-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090135-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090135-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090135-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090135-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090135-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090135-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090135-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090135-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090135-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090135-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090135-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090135-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090135-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090135-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2010-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090135-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2010-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090135-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	2010-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090135-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2010-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090135-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2010-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090135-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	2010-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090135-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2010-02-25	`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	A090135-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090135-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090135-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090135-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090135-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090135-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090135-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090135-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090135-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090135-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090135-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090135-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090135-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090135-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090135-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090135-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090135-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090135-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090135-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090135-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090135-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090135-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090135-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090135-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090135-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090135-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090135-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090135-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090135-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090135-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090135-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090135-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090135-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090135-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090135-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090135-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090135-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090135-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090135-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090135-005	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	5 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
85971b31-6f7d-421c-bf3c-5b33f3c1e781	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	SPL version
68462-259-01	ropinirole	100 in 1 BOTTLE	TABLET, FILM COATED	100	16
68462-259-10	ropinirole	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	16
68462-259-11	ropinirole	10 in 1 CARTON	TABLET, FILM COATED	10	16
68462-259-11	ropinirole	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-259-01	EA - Each	68462-259	98a8eef7-4a7a-408b-9d04-e6fa36055a11	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 [GLENMARK PHARMACEUTICALS INC., USA]	7
ROPINIROLE	ACTIVE MOIETY	030PYR8953	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-259	ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	15	Current NDC, Legacy NDC, 4 package rows	20240104_85971b31-6f7d-421c-bf3c-5b33f3c1e781.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	Preferred Pharmaceuticals Inc.	0030ffac-183a-472c-95b8-f93b4195de04	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090135 application number: ANDA090135
ropinirole	ROPINIROLE	REMEDYREPACK INC.	594081d7-2e03-4780-bdc2-bb5361839f2a	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090135 application number: ANDA090135
ropinirole	ROPINIROLE	Bryant Ranch Prepack	c89f68e5-d2ad-4aad-a63c-c32eff5e82c9	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090135 application number: ANDA090135
ropinirole	ROPINIROLE	Bryant Ranch Prepack	e32ef7a6-b4b6-4a22-a2ed-722255b486b4	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090135 application number: ANDA090135
ropinirole	ROPINIROLE	REMEDYREPACK INC.	864b38b0-1d4b-4da8-9645-c1760a2080ce	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090135 application number: ANDA090135
ropinirole	ROPINIROLE	REMEDYREPACK INC.	16752e1b-10eb-4c31-92d4-ff6c6e8466f4	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090135 application number: ANDA090135
ropinirole	ROPINIROLE	A-S Medication Solutions	35d0074e-212b-4a1f-9cd7-974ca08d2c95	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090135 application number: ANDA090135
ropinirole	ROPINIROLE	Glenmark Pharmaceuticals Inc., USA	85971b31-6f7d-421c-bf3c-5b33f3c1e781	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090135 application number: ANDA090135 ndc (product): 68462-259
ropinirole	ROPINIROLE	A-S Medication Solutions	ba358e45-09ab-46ed-986b-67affeb240a4	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090135 application number: ANDA090135
Ropinirole	ROPINIROLE	Direct_Rx	f3a9982a-015a-1134-e053-2a95a90ad2d4	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090135 application number: ANDA090135

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	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
312846	rOPINIRole HCl 0.5 MG Oral Tablet	PSN	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
314208	rOPINIRole HCl 1 MG Oral Tablet	PSN	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
312847	rOPINIRole HCl 2 MG Oral Tablet	PSN	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
283858	rOPINIRole HCl 3 MG Oral Tablet	PSN	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
562704	rOPINIRole HCl 4 MG Oral Tablet	PSN	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
312849	rOPINIRole HCl 5 MG Oral Tablet	PSN	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
312845	ropinirole 0.25 MG Oral Tablet	SCD	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
312846	ropinirole 0.5 MG Oral Tablet	SCD	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
314208	ropinirole 1 MG Oral Tablet	SCD	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
312847	ropinirole 2 MG Oral Tablet	SCD	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
283858	ropinirole 3 MG Oral Tablet	SCD	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
562704	ropinirole 4 MG Oral Tablet	SCD	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
312849	ropinirole 5 MG Oral Tablet	SCD	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
312845	ropinirole 0.25 MG (as ropinirole hydrochloride) Oral Tablet	SY	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
312846	ropinirole 0.5 MG (as ropinirole hydrochloride) Oral Tablet	SY	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
314208	ropinirole 1 MG (as ropinirole hydrochloride) Oral Tablet	SY	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
312847	ropinirole 2 MG (as ropinirole hydrochloride) Oral Tablet	SY	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
283858	ropinirole 3 MG (as ropinirole hydrochloride) Oral Tablet	SY	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
562704	ropinirole 4 MG (as ropinirole hydrochloride) Oral Tablet	SY	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16
312849	ropinirole 5 MG (as ropinirole hydrochloride) Oral Tablet	SY	85971b31-6f7d-421c-bf3c-5b33f3c1e781	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-259-01	68462025901	100 TABLET, FILM COATED in 1 BOTTLE (68462-259-01)		2010-02-25	0000-00-00	No	No	Current
68462-259-10	68462025910	1000 TABLET, FILM COATED in 1 BOTTLE (68462-259-10)		2010-02-25	0000-00-00	No	No	Current
68462-259-11	68462025911	10 BLISTER PACK in 1 CARTON (68462-259-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2010-02-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ropinirole	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-16	HUMAN PRESCRIPTION DRUG LABEL	16