Ropinirole

Product NDC
68151-4073
11-digit product format
681514073
Labeler code
68151
Product ID
68151-4073_91ad82ed-4768-4ac3-b44e-8dc21aa03c35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rOPINIRole
Dosage form
TABLET
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA077852
Marketing category
ANDA
Marketing start
2008-05-05
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
2018-12-31
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 productproduct68151-4073IInactivated by FDA2026-08-10
excluded packagepackage68151-407368151-4073-2IInactivated 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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68151-4073-2IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68151-4073-2IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68151-4073-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68151-4073-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68151-4073-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68151-4073-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68151-4073-2IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68151-4073-2IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68151-4073-2IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68151-4073-2IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68151-4073-2IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68151-4073-2IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68151-4073-2IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68151-4073-2IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68151-4073-2IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68151-4073-2IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68151-4073-2IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68151-4073-2IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68151-4073-2IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68151-4073-2IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68151-4073-2IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68151-4073-2EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
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…

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
68151-4073-2Ropinirole1 in 1 PACKAGETABLET13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4073ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_1cdb9d61-5bbc-4026-a449-fec8c9ce5c65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314208rOPINIRole HCl 1 MG Oral TabletPSN1cdb9d61-5bbc-4026-a449-fec8c9ce5c653
314208ropinirole 1 MG Oral TabletSCD1cdb9d61-5bbc-4026-a449-fec8c9ce5c653
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY1cdb9d61-5bbc-4026-a449-fec8c9ce5c653

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4073-2681514073021 in 1 PACKAGEHistorical