ropinirole

Product NDC
50090-4804
Requested package NDC
50090-4804-0
11-digit product format
500904804
Labeler code
50090
Product ID
50090-4804_036f14fd-412a-4a69-9a20-db2701bffe57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204022
Marketing category
ANDA
Marketing start
2018-10-17
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
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 packagepackage50090-480450090-4804-0IInactivated by FDA2026-08-10

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A204022-001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2017-02-28
A204022-002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2017-02-28
A204022-003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2017-02-28
A204022-004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2017-02-28
A204022-005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2017-02-28
A204022-006ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2017-02-28
A204022-007ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2017-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204022-001AB
A204022-002AB
A204022-003AB
A204022-004AB
A204022-005AB
A204022-006AB
A204022-007AB

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 · 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 UTC2026-02A204022-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2017-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204022-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2017-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204022-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2017-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204022-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2017-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204022-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2017-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204022-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2017-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204022-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2017-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204022-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2017-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204022-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2017-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204022-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2017-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204022-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2017-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204022-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2017-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204022-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2017-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204022-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2017-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204022-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2017-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204022-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2017-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204022-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2017-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204022-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2017-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204022-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2017-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204022-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2017-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204022-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2017-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204022-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2017-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204022-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2017-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204022-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2017-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204022-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2017-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204022-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2017-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204022-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2017-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204022-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2017-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204022-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2017-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204022-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2017-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204022-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2017-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204022-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2017-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204022-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2017-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204022-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2017-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204022-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2017-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204022-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2017-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204022-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2017-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204022-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2017-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204022-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2017-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204022-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2017-02-2803ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204022-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204022-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204022-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204022-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204022-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204022-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204022-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204022-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204022-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204022-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204022-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204022-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204022-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204022-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204022-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204022-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204022-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204022-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204022-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204022-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204022-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204022-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204022-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204022-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204022-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204022-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204022-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204022-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204022-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204022-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204022-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204022-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204022-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204022-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204022-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204022-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204022-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204022-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204022-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204022-005AB103ed91905a0d…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4804-0ropinirole1 in 1 CARTONTABLET, FILM COATED11
50090-4804-0ropinirole33 in 1 BLISTER PACKTABLET, FILM COATED331

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4804-0EA - Each50090-480495e85c63-2d3f-4023-8404-858022e9400612023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4804ROPINIROLE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20221206_88b5baf6-bf5c-4b87-8910-d72e26ba18ee.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RopiniroleROPINIROLEDirect_Rxe1fb0b51-4f8a-965d-e053-2a95a90ad9362025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204022
application number: ANDA204022
ROPINIROLEROPINIROLEDIRECT RXc2c38b4c-b139-45f2-e053-2995a90a262c2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204022
application number: ANDA204022
ropiniroleROPINIROLEBryant Ranch Prepack8ebaa083-9f72-4e43-a4c4-36e3e7b5d5f22024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204022
application number: ANDA204022
ropiniroleROPINIROLEBryant Ranch Prepackceb3a0cb-8677-4acd-8313-5498201e81d92024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204022
application number: ANDA204022
ropiniroleROPINIROLEBryant Ranch Prepackcb378fb5-6dca-43e9-83bc-3c54eb9c1af72024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204022
application number: ANDA204022
ropiniroleROPINIROLEBryant Ranch Prepack55bb5cf4-0e12-41b0-bc52-50b26fe408de2024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204022
application number: ANDA204022
ropiniroleROPINIROLEAccord Healthcare Inc.4a2a5b63-5b14-6975-e054-00144ff8d46c2024-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204022
application number: ANDA204022
ropiniroleROPINIROLEA-S Medication Solutions4f4729f8-c910-4a09-a4b4-b4243e7f01052024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204022
application number: ANDA204022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN88b5baf6-bf5c-4b87-8910-d72e26ba18ee1
312845ropinirole 0.25 MG Oral TabletSCD88b5baf6-bf5c-4b87-8910-d72e26ba18ee1
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY88b5baf6-bf5c-4b87-8910-d72e26ba18ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4804-0500904804001 BLISTER PACK in 1 CARTON (50090-4804-0) > 33 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2019-12-200000-00-00NoNoCurrent