ROPINIROLE HYDROCHLORIDE

Product NDC
21695-794
11-digit product format
216950794
Labeler code
21695
Product ID
21695-794_1cb783ed-5496-4b4d-995b-e81157f9f8d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPINIROLE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA078230
Marketing category
ANDA
Marketing start
2008-05-21
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
E
Listing certified through
2017-12-31
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 productproduct21695-794IInactivated by FDA2026-08-03
excluded packagepackage21695-79421695-794-60IInactivated by FDA2026-08-03

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 · 44 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 packagepackage21695-794-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-794-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-794-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-794-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-794-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-794-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-794-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-794-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-794-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-794-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-794-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-794-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-794-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-794-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-794-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-794-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-794-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-794-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-794-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-794-60e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-794-609bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-794-60110d247fa046…a55b01930146…

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
A078230-001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-20
A078230-002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-20
A078230-003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-20
A078230-004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-20
A078230-005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-20
A078230-006ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2008-05-20
A078230-007ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2008-05-20

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 UTC2026-02A078230-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078230-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078230-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078230-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078230-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078230-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2008-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078230-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2008-05-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078230-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078230-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078230-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078230-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078230-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078230-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2008-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078230-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2008-05-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078230-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078230-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078230-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078230-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078230-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078230-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2008-05-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078230-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2008-05-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078230-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078230-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078230-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078230-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078230-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078230-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2008-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078230-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2008-05-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078230-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078230-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078230-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078230-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078230-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078230-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORAL2008-05-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078230-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2008-05-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078230-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORAL2008-05-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078230-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORAL2008-05-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078230-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORAL2008-05-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078230-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORAL2008-05-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078230-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORAL2008-05-2003ed91905a0d…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
dc920868-8845-b908-7ca8-0dee3e345af5Product name220230123
e24bc1b4-1e16-908e-3d09-29da3ca2fb1fProduct name220170517

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-794-602019-09-24C16284748780-1934fe258-4b66-48b1-e053-8cdaa90a720aRopinirole Hydrochloride Tablets 0.25 mg, 1 mg and 5 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-794-60ROPINIROLE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET, COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-794-60EA - Each21695-794f8848374-f390-4488-be2c-6716d7fb146012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE HYDROCHLORIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UROPINIROLE HYDROCHLORIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROPINIROLE HYDROCHLORIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE HYDROCHLORIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ROPINIROLE HYDROCHLORIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOROPINIROLE HYDROCHLORIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LROPINIROLE HYDROCHLORIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XROPINIROLE HYDROCHLORIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE HYDROCHLORIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AROPINIROLE HYDROCHLORIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HROPINIROLE HYDROCHLORIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROPINIROLE HYDROCHLORIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-794ROPINIROLE HYDROCHLORIDE TABLET, COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101201_1cb783ed-5496-4b4d-995b-e81157f9f8d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN1cb783ed-5496-4b4d-995b-e81157f9f8d11
314208rOPINIRole HCl 1 MG Oral TabletPSN1cb783ed-5496-4b4d-995b-e81157f9f8d11
312849rOPINIRole HCl 5 MG Oral TabletPSN1cb783ed-5496-4b4d-995b-e81157f9f8d11
312845ropinirole 0.25 MG Oral TabletSCD1cb783ed-5496-4b4d-995b-e81157f9f8d11
314208ropinirole 1 MG Oral TabletSCD1cb783ed-5496-4b4d-995b-e81157f9f8d11
312849ropinirole 5 MG Oral TabletSCD1cb783ed-5496-4b4d-995b-e81157f9f8d11
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY1cb783ed-5496-4b4d-995b-e81157f9f8d11
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY1cb783ed-5496-4b4d-995b-e81157f9f8d11
312849ropinirole 5 MG (as ropinirole hydrochloride) Oral TabletSY1cb783ed-5496-4b4d-995b-e81157f9f8d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-794-602169507946060 in 1 BOTTLE, PLASTICHistorical