Ropinirole

Product NDC
0054-0117
11-digit product format
000540117
Labeler code
0054
Product ID
0054-0117_89b0f8ed-b89f-461b-a0d7-6a52a82aa57d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rOPINIRole
Dosage form
TABLET
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp.
Application
ANDA077852
Marketing category
ANDA
Marketing start
2008-05-05
Marketing end
2021-04-09
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct0054-0117DDiscontinued by firm2026-08-10
excluded packagepackage0054-01170054-0117-25DDiscontinued 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 packagepackage0054-0117-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0054-0117-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0054-0117-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0054-0117-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0054-0117-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0054-0117-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0054-0117-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-0117-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-0117-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-0117-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-0117-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-0117-25557ba5c1ecfa…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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc920868-8845-b908-7ca8-0dee3e345af5Product name220230123
e24bc1b4-1e16-908e-3d09-29da3ca2fb1fProduct name220170517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0117-25EA - Each0054-01171be7f45b-ed94-4521-ba0b-8480fe17e05412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE TABLET [ROXANE LABORATORIES, INC]5
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET [ROXANE LABORATORIES, INC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UROPINIROLE TABLET [ROXANE LABORATORIES, INC]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROPINIROLE TABLET [ROXANE LABORATORIES, INC]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GROPINIROLE TABLET [ROXANE LABORATORIES, INC]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE TABLET [ROXANE LABORATORIES, INC]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAROPINIROLE TABLET [ROXANE LABORATORIES, INC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ROPINIROLE TABLET [ROXANE LABORATORIES, INC]5
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GROPINIROLE TABLET [ROXANE LABORATORIES, INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE TABLET [ROXANE LABORATORIES, INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ROPINIROLE TABLET [ROXANE LABORATORIES, INC]5
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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312846rOPINIRole HCl 0.5 MG Oral TabletPSN366a173b-d6a0-4c96-8539-dad363159d983
312846ropinirole 0.5 MG Oral TabletSCD366a173b-d6a0-4c96-8539-dad363159d983
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY366a173b-d6a0-4c96-8539-dad363159d983

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0117-2500054011725100 TABLET in 1 BOTTLE (0054-0117-25) 100 tablet2008-05-052021-04-09NoNoCurrent