Ropinirole

Product NDC: 64850-254
11-digit product format: 648500254
Labeler code: 64850
Product ID: 64850-254_0ca68ebf-b908-4be4-a1a0-f9b3359375a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ropinirole
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Elite Laboratories, Inc.
Application: ANDA217862
Marketing category: ANDA
Marketing start: 2025-11-10
Substance: ROPINIROLE HYDROCHLORIDE
Active strength: 12 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
A217862-001	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10
A217862-002	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10
A217862-003	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10
A217862-004	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10
A217862-005	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217862-001	AB
A217862-002	AB
A217862-003	AB
A217862-004	AB
A217862-005	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.

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	A217862-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217862-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217862-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217862-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217862-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217862-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217862-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217862-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217862-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217862-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217862-001	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217862-002	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217862-003	ROPINIROLE HYDROCHLORIDE	EQ 6MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217862-004	ROPINIROLE HYDROCHLORIDE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217862-005	ROPINIROLE HYDROCHLORIDE	EQ 12MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2025-11-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217862-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217862-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217862-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217862-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217862-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217862-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217862-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217862-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217862-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217862-005	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217862-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217862-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217862-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217862-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217862-005	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ROPINIROLE HYDROCHLORIDE	12 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 · 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
307411be-1c4e-44f7-b94d-737a3384c107	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
dc920868-8845-b908-7ca8-0dee3e345af5	Product name	2	20230123
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
e24bc1b4-1e16-908e-3d09-29da3ca2fb1f	Product name	2	20170517
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64850-254-30	Ropinirole	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64850-254-30	EA - Each	64850-254	60365b6e-7d90-457c-8fb6-d90a852ebd6a	1	2026-04-20

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ropinirole	ROPINIROLE	Bryant Ranch Prepack	f83a834c-807d-4f2c-9624-59fcf303b5e1	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217862 application number: ANDA217862
Ropinirole	ROPINIROLE	Bryant Ranch Prepack	bdd6181f-f582-49c2-8adc-c771f5b01010	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217862 application number: ANDA217862
Ropinirole	ROPINIROLE	Bryant Ranch Prepack	518e7407-8ef2-4596-8218-c318b4fd7634	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217862 application number: ANDA217862
Ropinirole	ROPINIROLE	Bryant Ranch Prepack	d0f9a662-519a-4359-a703-bb0e9d3d54f1	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217862 application number: ANDA217862
Ropinirole	ROPINIROLE	Bryant Ranch Prepack	ee70202a-8947-4680-a090-ad1f349fdc1a	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217862 application number: ANDA217862
Ropinirole	ROPINIROLE	Elite Laboratories, Inc.	307411be-1c4e-44f7-b94d-737a3384c107	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217862 application number: ANDA217862 ndc (product): 64850-254

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
824959	rOPINIRole 12 MG 24HR Extended Release Oral Tablet	PSN	307411be-1c4e-44f7-b94d-737a3384c107	6
799055	rOPINIRole 2 MG 24HR Extended Release Oral Tablet	PSN	307411be-1c4e-44f7-b94d-737a3384c107	6
799056	rOPINIRole 4 MG 24HR Extended Release Oral Tablet	PSN	307411be-1c4e-44f7-b94d-737a3384c107	6
848582	rOPINIRole 6 MG 24HR Extended Release Oral Tablet	PSN	307411be-1c4e-44f7-b94d-737a3384c107	6
799054	rOPINIRole 8 MG 24HR Extended Release Oral Tablet	PSN	307411be-1c4e-44f7-b94d-737a3384c107	6
824959	24 HR ropinirole 12 MG Extended Release Oral Tablet	SCD	307411be-1c4e-44f7-b94d-737a3384c107	6
799055	24 HR ropinirole 2 MG Extended Release Oral Tablet	SCD	307411be-1c4e-44f7-b94d-737a3384c107	6
799056	24 HR ropinirole 4 MG Extended Release Oral Tablet	SCD	307411be-1c4e-44f7-b94d-737a3384c107	6
848582	24 HR ropinirole 6 MG Extended Release Oral Tablet	SCD	307411be-1c4e-44f7-b94d-737a3384c107	6
799054	24 HR ropinirole 8 MG Extended Release Oral Tablet	SCD	307411be-1c4e-44f7-b94d-737a3384c107	6
824959	ropinirole 12 MG (as ropinirole hydrochloride 13.68 MG) 24 HR Extended Release Oral Tablet	SY	307411be-1c4e-44f7-b94d-737a3384c107	6
824959	ropinirole 12 MG 24 HR Extended Release Oral Tablet	SY	307411be-1c4e-44f7-b94d-737a3384c107	6
799055	ropinirole 2 MG (as ropinirole hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet	SY	307411be-1c4e-44f7-b94d-737a3384c107	6
799055	ropinirole 2 MG 24 HR Extended Release Oral Tablet	SY	307411be-1c4e-44f7-b94d-737a3384c107	6
799056	ropinirole 4 MG (as ropinirole hydrochloride 4.56 MG) 24 HR Extended Release Oral Tablet	SY	307411be-1c4e-44f7-b94d-737a3384c107	6
799056	ropinirole 4 MG 24 HR Extended Release Oral Tablet	SY	307411be-1c4e-44f7-b94d-737a3384c107	6
848582	ropinirole 6 MG (ropinirole hydrochloride 6.84 MG) 24 HR Extended Release Oral Tablet	SY	307411be-1c4e-44f7-b94d-737a3384c107	6
848582	ropinirole 6 MG 24 HR Extended Release Oral Tablet	SY	307411be-1c4e-44f7-b94d-737a3384c107	6
799054	ropinirole 8 MG (as ropinirole hydrochloride 9.12 MG) 24 HR Extended Release Oral Tablet	SY	307411be-1c4e-44f7-b94d-737a3384c107	6
799054	ropinirole 8 MG 24 HR Extended Release Oral Tablet	SY	307411be-1c4e-44f7-b94d-737a3384c107	6
824959	rOPINIRole 12 MG 24HR Extended Release Oral Tablet	PSN	ee70202a-8947-4680-a090-ad1f349fdc1a	2
824959	24 HR ropinirole 12 MG Extended Release Oral Tablet	SCD	ee70202a-8947-4680-a090-ad1f349fdc1a	2
824959	ropinirole 12 MG (as ropinirole hydrochloride 13.68 MG) 24 HR Extended Release Oral Tablet	SY	ee70202a-8947-4680-a090-ad1f349fdc1a	2
824959	ropinirole 12 MG 24 HR Extended Release Oral Tablet	SY	ee70202a-8947-4680-a090-ad1f349fdc1a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
64850-254-30	64850025430	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (64850-254-30)	2025-11-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ropinirole	Bryant Ranch Prepack	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	2
Ropinirole	Elite Laboratories, Inc.	2025-11-10	HUMAN PRESCRIPTION DRUG LABEL	6