FDA.reportPublic FDA data

Ropinirole Hydrochloride

Product NDC
64220-420
11-digit product format
642200420
Labeler code
64220
Product ID
64220-420_db5b7681-1e06-4ff2-a0c1-5304b298f0f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropinirole Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zhejiang Huahai Pharmaceutical Co., Ltd.
Application
ANDA078110
Marketing category
ANDA
Marketing start
2011-08-10
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
0 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64220-420IInactivated by FDA2026-07-31
excluded packagepackage64220-42064220-420-01IInactivated by FDA2026-07-31
excluded packagepackage64220-42064220-420-02IInactivated 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
64220-420-012019-10-29C16284748780-1960f7f55-d82f-8e05-e053-dbdaa90a074aRopinirole Hydrochloride Tablets
64220-420-022019-10-29C16284748780-1960f7f55-d82f-8e05-e053-dbdaa90a074aRopinirole Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64220-420-01Ropinirole Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
64220-420-02Ropinirole Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64220-420ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.]2Legacy NDC, 2 package rows20110916_6f7fc849-8a38-47a1-bc39-54801a86416c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN6f7fc849-8a38-47a1-bc39-54801a86416c2
312846rOPINIRole HCl 0.5 MG Oral TabletPSN6f7fc849-8a38-47a1-bc39-54801a86416c2
314208rOPINIRole HCl 1 MG Oral TabletPSN6f7fc849-8a38-47a1-bc39-54801a86416c2
312847rOPINIRole HCl 2 MG Oral TabletPSN6f7fc849-8a38-47a1-bc39-54801a86416c2
283858rOPINIRole HCl 3 MG Oral TabletPSN6f7fc849-8a38-47a1-bc39-54801a86416c2
562704rOPINIRole HCl 4 MG Oral TabletPSN6f7fc849-8a38-47a1-bc39-54801a86416c2
312849rOPINIRole HCl 5 MG Oral TabletPSN6f7fc849-8a38-47a1-bc39-54801a86416c2
312845ropinirole 0.25 MG Oral TabletSCD6f7fc849-8a38-47a1-bc39-54801a86416c2
312846ropinirole 0.5 MG Oral TabletSCD6f7fc849-8a38-47a1-bc39-54801a86416c2
314208ropinirole 1 MG Oral TabletSCD6f7fc849-8a38-47a1-bc39-54801a86416c2
312847ropinirole 2 MG Oral TabletSCD6f7fc849-8a38-47a1-bc39-54801a86416c2
283858ropinirole 3 MG Oral TabletSCD6f7fc849-8a38-47a1-bc39-54801a86416c2
562704ropinirole 4 MG Oral TabletSCD6f7fc849-8a38-47a1-bc39-54801a86416c2
312849ropinirole 5 MG Oral TabletSCD6f7fc849-8a38-47a1-bc39-54801a86416c2
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY6f7fc849-8a38-47a1-bc39-54801a86416c2
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY6f7fc849-8a38-47a1-bc39-54801a86416c2
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY6f7fc849-8a38-47a1-bc39-54801a86416c2
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY6f7fc849-8a38-47a1-bc39-54801a86416c2
283858ropinirole 3 MG (as ropinirole hydrochloride) Oral TabletSY6f7fc849-8a38-47a1-bc39-54801a86416c2
562704ropinirole 4 MG (as ropinirole hydrochloride) Oral TabletSY6f7fc849-8a38-47a1-bc39-54801a86416c2
312849ropinirole 5 MG (as ropinirole hydrochloride) Oral TabletSY6f7fc849-8a38-47a1-bc39-54801a86416c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64220-420-0164220042001100 in 1 BOTTLEHistorical
64220-420-0264220042002500 in 1 BOTTLEHistorical