ropinirole hydrochloride

Product NDC: 43547-273
11-digit product format: 435470273
Labeler code: 43547
Product ID: 43547-273_0e04048a-c22c-4c6b-9c00-91906541a95a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ropinirole hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: SOLCO HEALTHCARE US, LLC
Application: ANDA078110
Marketing category: ANDA
Marketing start: 2011-09-20
Substance: ROPINIROLE HYDROCHLORIDE
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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078110-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05
A078110-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05
A078110-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05
A078110-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05
A078110-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05
A078110-006	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05
A078110-007	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078110-001	AB
A078110-002	AB
A078110-003	AB
A078110-004	AB
A078110-005	AB
A078110-006	AB
A078110-007	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-006	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2008-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-007	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078110-001	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET / ORAL	AB	RS	2008-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078110-002	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2008-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078110-003	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2008-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078110-004	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		2008-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078110-005	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2008-05-05	`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	A078110-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078110-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078110-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078110-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078110-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078110-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078110-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078110-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078110-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078110-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078110-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078110-005	AB	1	`03ed91905a0d…`

Additional Listing Data#

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

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
7734ef0b-584f-42dd-a8b5-adbdf4e4df93	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
43547-273-10	2020-04-08	These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997
43547-273-50	2020-04-08	These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997
43547-273-10	2020-01-31	These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997
43547-273-50	2020-01-31	These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43547-273-10	ropinirole hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		17
43547-273-50	ropinirole hydrochloride	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-273-10	EA - Each	43547-273	874b20ec-545b-4e03-9545-a7e7274a81c5	1	2012-07-24
43547-273-50	EA - Each	43547-273	763de863-9f76-460b-b70d-57a9832208ad	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ROPINIROLE HYDROCHLORIDE	ACTIVE INGREDIENT	D7ZD41RZI9	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
ROPINIROLE	ACTIVE MOIETY	030PYR8953	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
COCHINEAL	INACTIVE INGREDIENT	TZ8Z31B35M	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-273	ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	15	Current NDC, Legacy NDC, 2 package rows	20220322_7734ef0b-584f-42dd-a8b5-adbdf4e4df93.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 hydrochloride	ROPINIROLE HYDROCHLORIDE	A-S Medication Solutions	a97d5e2d-4a17-4d80-9216-1b0780199502	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Northwind Health Company, LLC	ab6d21b6-2584-4b97-e053-2a95a90adc50	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	SOLCO HEALTHCARE US, LLC	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110 ndc (product): 43547-273
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	SOLCO HEALTHCARE US, LLC	5823b3a2-3256-4d94-97b4-ec6b940312f4	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	AvPAK	e699a31a-25fc-554b-e053-2a95a90a843a	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	American Health Packaging	6849b3c0-e36b-4bea-82f2-b33ae3d44c95	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Bryant Ranch Prepack	6c10444a-48da-469d-bf8f-1e6e0b7e15f8	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	Proficient Rx LP	89e3865c-1fe1-4f29-9606-8830df4bbe53	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110
ropinirole hydrochloride	ROPINIROLE HYDROCHLORIDE	A-S Medication Solutions	9c4dacc6-cebc-4f42-85fc-41083512b290	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078110 application number: ANDA078110

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D7ZD41RZI9	ROPINIROLE HYDROCHLORIDE	91374-20-8	ROPINIROLE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312845	rOPINIRole HCl 0.25 MG Oral Tablet	PSN	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
312846	rOPINIRole HCl 0.5 MG Oral Tablet	PSN	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
314208	rOPINIRole HCl 1 MG Oral Tablet	PSN	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
312847	rOPINIRole HCl 2 MG Oral Tablet	PSN	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
283858	rOPINIRole HCl 3 MG Oral Tablet	PSN	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
562704	rOPINIRole HCl 4 MG Oral Tablet	PSN	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
312849	rOPINIRole HCl 5 MG Oral Tablet	PSN	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
312845	ropinirole 0.25 MG Oral Tablet	SCD	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
312846	ropinirole 0.5 MG Oral Tablet	SCD	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
314208	ropinirole 1 MG Oral Tablet	SCD	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
312847	ropinirole 2 MG Oral Tablet	SCD	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
283858	ropinirole 3 MG Oral Tablet	SCD	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
562704	ropinirole 4 MG Oral Tablet	SCD	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
312849	ropinirole 5 MG Oral Tablet	SCD	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
312845	ropinirole 0.25 MG (as ropinirole hydrochloride) Oral Tablet	SY	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
312846	ropinirole 0.5 MG (as ropinirole hydrochloride) Oral Tablet	SY	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
314208	ropinirole 1 MG (as ropinirole hydrochloride) Oral Tablet	SY	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
312847	ropinirole 2 MG (as ropinirole hydrochloride) Oral Tablet	SY	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
283858	ropinirole 3 MG (as ropinirole hydrochloride) Oral Tablet	SY	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
562704	ropinirole 4 MG (as ropinirole hydrochloride) Oral Tablet	SY	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
312849	ropinirole 5 MG (as ropinirole hydrochloride) Oral Tablet	SY	7734ef0b-584f-42dd-a8b5-adbdf4e4df93	17
562704	rOPINIRole HCl 4 MG Oral Tablet	PSN	38ec83ba-064b-4d35-a7e4-3d5d8362b18d	3
562704	ropinirole 4 MG Oral Tablet	SCD	38ec83ba-064b-4d35-a7e4-3d5d8362b18d	3
562704	ropinirole 4 MG (as ropinirole hydrochloride) Oral Tablet	SY	38ec83ba-064b-4d35-a7e4-3d5d8362b18d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-273-10	43547027310	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-273-10)	2011-09-20	0000-00-00	No	No	Current
43547-273-50	43547027350	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-273-50)	2011-09-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ropinirole hydrochloride	SOLCO HEALTHCARE US, LLC	2025-05-30	HUMAN PRESCRIPTION DRUG LABEL	17
ropinirole hydrochloride	A-S Medication Solutions	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	3