FDA.reportPublic FDA data

ropinirole hydrochloride

Product NDC
63629-4798
Requested package NDC
63629-4798-1
11-digit product format
636294798
Labeler code
63629
Product ID
63629-4798_a77fe0b5-6a7f-413e-a6c9-952a1b2b1506
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078110
Marketing category
ANDA
Marketing start
2011-09-20
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage63629-479863629-4798-1IInactivated 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
63629-4798-12024-01-30C16284748780-19855e2a2-3726-60a7-e053-dbdaa90a05bdThese 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
63629-4798-22024-01-30C16284748780-19855e2a2-3726-60a7-e053-dbdaa90a05bdThese 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
63629-4798-32024-01-30C16284748780-19855e2a2-3726-60a7-e053-dbdaa90a05bdThese 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
63629-4798-42024-01-30C16284748780-19855e2a2-3726-60a7-e053-dbdaa90a05bdThese 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
63629-4798-52024-01-30C16284748780-19855e2a2-3726-60a7-e053-dbdaa90a05bdThese 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
63629-4798-12020-10-12C16284748780-19855e2a2-3726-60a7-e053-dbdaa90a05bdThese 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
63629-4798-22020-10-12C16284748780-19855e2a2-3726-60a7-e053-dbdaa90a05bdThese 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
63629-4798-12019-11-27C16284748780-19855e2a2-3726-60a7-e053-dbdaa90a05bdThese 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
63629-4798-22019-11-27C16284748780-19855e2a2-3726-60a7-e053-dbdaa90a05bdThese 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
63629-4798-1ropinirole hydrochloride30 in 1 BOTTLETABLET, FILM COATED301006
63629-4798-2ropinirole hydrochloride60 in 1 BOTTLETABLET, FILM COATED601006
63629-4798-3ropinirole hydrochloride90 in 1 BOTTLETABLET, FILM COATED901006
63629-4798-4ropinirole hydrochloride28 in 1 BOTTLETABLET, FILM COATED281006
63629-4798-5ropinirole hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
TALCINACTIVE INGREDIENT7SEV7J4R1UROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4798ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1006Legacy NDC, 5 package rows20220505_8e23aac9-446c-43b5-89ab-fc596b766df0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312846rOPINIRole HCl 0.5 MG Oral TabletPSN8e23aac9-446c-43b5-89ab-fc596b766df01006
312846ropinirole 0.5 MG Oral TabletSCD8e23aac9-446c-43b5-89ab-fc596b766df01006
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY8e23aac9-446c-43b5-89ab-fc596b766df01006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4798-16362947980130 TABLET, FILM COATED in 1 BOTTLE (63629-4798-1) 2015-09-030000-00-00NoNoCurrent