FDA.reportPublic FDA data

ropinirole hydrochloride

Product NDC
50090-4810
Requested package NDC
50090-4810-0
11-digit product format
500904810
Labeler code
50090
Product ID
50090-4810_bceb077b-808c-4f18-9725-f2ee15b0835c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078110
Marketing category
ANDA
Marketing start
2011-09-20
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-481050090-4810-0IInactivated by FDA2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078110-001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALABRS2008-05-05
A078110-002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-05
A078110-003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-05
A078110-004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-05
A078110-005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-05
A078110-006ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2008-05-05
A078110-007ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2008-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078110-001AB
A078110-002AB
A078110-003AB
A078110-004AB
A078110-005AB
A078110-006AB
A078110-007AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078110-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALABRS2008-05-05a50c72e98297…
2026-08-01 22:54:322026-06A078110-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-05a50c72e98297…
2026-08-01 22:54:322026-06A078110-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-05a50c72e98297…
2026-08-01 22:54:322026-06A078110-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-05a50c72e98297…
2026-08-01 22:54:322026-06A078110-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-05a50c72e98297…
2026-08-01 22:54:322026-06A078110-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2008-05-05a50c72e98297…
2026-08-01 22:54:322026-06A078110-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2008-07-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078110-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078110-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078110-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A078110-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A078110-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A078110-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A078110-007AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEA-S Medication Solutionsa97d5e2d-4a17-4d80-9216-1b07801995022026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDENorthwind Health Company, LLCab6d21b6-2584-4b97-e053-2a95a90adc502026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDESOLCO HEALTHCARE US, LLC7734ef0b-584f-42dd-a8b5-adbdf4e4df932025-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDESOLCO HEALTHCARE US, LLC5823b3a2-3256-4d94-97b4-ec6b940312f42025-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEAvPAKe699a31a-25fc-554b-e053-2a95a90a843a2025-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEAmerican Health Packaging6849b3c0-e36b-4bea-82f2-b33ae3d44c952025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEBryant Ranch Prepack6c10444a-48da-469d-bf8f-1e6e0b7e15f82023-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEProficient Rx LP89e3865c-1fe1-4f29-9606-8830df4bbe532023-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEA-S Medication Solutions9c4dacc6-cebc-4f42-85fc-41083512b2902023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc920868-8845-b908-7ca8-0dee3e345af5Product name220230123
e24bc1b4-1e16-908e-3d09-29da3ca2fb1fProduct name220170517

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4810-02023-01-30C16284748780-1f386c64a-151c-0266-e053-dadaa90a7c1aThese 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 NDCProductDescriptionFormQuantityStrengthSPL version
50090-4810-0ropinirole hydrochloride30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4810ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20210416_38ec83ba-064b-4d35-a7e4-3d5d8362b18d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562704rOPINIRole HCl 4 MG Oral TabletPSN38ec83ba-064b-4d35-a7e4-3d5d8362b18d3
562704ropinirole 4 MG Oral TabletSCD38ec83ba-064b-4d35-a7e4-3d5d8362b18d3
562704ropinirole 4 MG (as ropinirole hydrochloride) Oral TabletSY38ec83ba-064b-4d35-a7e4-3d5d8362b18d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4810-05009048100030 TABLET, FILM COATED in 1 BOTTLE (50090-4810-0) 2019-12-260000-00-00NoNoCurrent