ropinirole hydrochloride

Product NDC
65841-718
Requested package NDC
65841-718-10
11-digit product format
658410718
Labeler code
65841
Product ID
65841-718_82436c19-cab1-4857-9a7d-9e32e4ba0f72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA090411
Marketing category
ANDA
Marketing start
2009-09-23
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
5 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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65841-71865841-718-10DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65841-71865841-718-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65841-71865841-718-10DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090411-001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2009-06-01
A090411-002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2009-06-01
A090411-003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2009-06-01
A090411-004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2009-06-01
A090411-005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2009-06-01
A090411-006ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2009-06-01
A090411-007ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2009-06-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090411-001AB
A090411-002AB
A090411-003AB
A090411-004AB
A090411-005AB
A090411-006AB
A090411-007AB

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.

Product history page 1 of 8 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090411-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2009-06-0184e616aacf4f…
2026-09-14 22:38:342026-08A090411-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2009-06-0184e616aacf4f…
2026-09-14 22:38:342026-08A090411-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2009-06-0184e616aacf4f…
2026-09-14 22:38:342026-08A090411-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2009-06-0184e616aacf4f…
2026-09-14 22:38:342026-08A090411-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2009-06-0184e616aacf4f…
2026-09-14 22:38:342026-08A090411-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2009-06-0184e616aacf4f…
2026-09-14 22:38:342026-08A090411-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2009-06-0184e616aacf4f…
2026-08-18 06:07:402026-07A090411-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2009-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07A090411-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2009-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07A090411-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2009-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07A090411-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2009-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07A090411-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2009-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07A090411-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2009-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07A090411-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2009-06-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090411-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2009-06-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090411-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2009-06-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090411-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2009-06-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090411-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2009-06-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090411-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2009-06-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090411-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2009-06-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090411-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2009-06-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090411-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2009-06-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090411-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2009-06-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090411-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2009-06-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090411-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2009-06-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090411-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2009-06-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090411-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2009-06-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090411-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2009-06-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090411-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2009-06-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090411-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2009-06-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090411-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2009-06-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090411-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2009-06-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090411-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2009-06-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090411-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2009-06-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090411-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2009-06-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090411-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2009-06-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090411-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2009-06-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090411-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2009-06-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090411-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2009-06-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090411-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2009-06-01fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090411-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090411-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090411-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A090411-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A090411-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A090411-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A090411-007AB184e616aacf4f…
2026-08-18 06:07:402026-07A090411-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090411-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090411-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090411-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090411-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090411-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090411-007AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090411-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090411-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090411-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090411-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090411-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090411-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090411-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090411-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090411-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090411-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090411-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090411-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090411-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090411-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090411-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090411-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090411-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090411-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090411-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090411-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090411-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090411-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090411-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090411-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090411-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090411-005AB1fd3edfee7708…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
COCHINEALINACTIVE INGREDIENTTZ8Z31B35MROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-718ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]7Legacy NDC20221109_5525c364-3574-4029-89dc-1efc6d85c03c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65841-718-10658410718101000 TABLET, FILM COATED in 1 BOTTLE (65841-718-10) 2009-09-230000-00-00NoNoCurrent