FDA.reportPublic FDA data

Ropinirole

Product NDC
50090-2850
11-digit product format
500902850
Labeler code
50090
Product ID
50090-2850_d892ea71-643f-4e49-8f84-426660e69873
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rOPINIRole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077852
Marketing category
ANDA
Marketing start
2008-05-05
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
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-2850DDiscontinued by firm2026-08-10
excluded packagepackage50090-285050090-2850-0DDiscontinued by firm2026-08-10

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2850-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2850-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2850-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2850-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2850-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2850-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2850-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2850-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2850-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-2850-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-2850-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-2850-0557ba5c1ecfa…9c80585c8c6e…

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
A077852-001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-05
A077852-002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-05
A077852-003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-05
A077852-004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-05
A077852-005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-05
A077852-006ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2008-05-05
A077852-007ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2008-05-19

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 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077852-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077852-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077852-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077852-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077852-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077852-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2008-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077852-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2008-05-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077852-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077852-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077852-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077852-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077852-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077852-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2008-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077852-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2008-05-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077852-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077852-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077852-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077852-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077852-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077852-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2008-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077852-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2008-05-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077852-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077852-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077852-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077852-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077852-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077852-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2008-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077852-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2008-05-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077852-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077852-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077852-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077852-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077852-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077852-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2008-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077852-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2008-05-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077852-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077852-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077852-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077852-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077852-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-0503ed91905a0d…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077852-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077852-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077852-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077852-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077852-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077852-006AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077852-007AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077852-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077852-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077852-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077852-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077852-005AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077852-006AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077852-007AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077852-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077852-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077852-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077852-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077852-005AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077852-006AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077852-007AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077852-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077852-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077852-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077852-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077852-005AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077852-006AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077852-007AB1ea99ee380514…