ROPINIROLE

Product NDC
61919-780
Requested package NDC
61919-780-90
11-digit product format
619190780
Labeler code
61919
Product ID
61919-780_cc0df9b3-16e9-d642-e053-2a95a90a7726
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPINIROLE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090429
Marketing category
ANDA
Marketing start
2019-01-14
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
3 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage61919-78061919-780-90DDiscontinued by firm2026-08-03

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 · 12 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…

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
A090429-001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-03-24
A090429-002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-03-24
A090429-003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-03-24
A090429-004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-03-24
A090429-005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-03-24
A090429-006ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-03-24
A090429-007ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090429-001AB
A090429-002AB
A090429-003AB
A090429-004AB
A090429-005AB
A090429-006AB
A090429-007AB

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 UTC2026-02A090429-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090429-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-03-2403ed91905a0d…

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 UTC2026-02A090429-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090429-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-005AB103ed91905a0d…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-780-30EA - Each61919-780976c8c3b-bb47-4e10-903d-eb17558f967d12019-11-12

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ROPINIROLEROPINIROLECardinal Health 107, LLC7bf874a3-4d45-41ab-9796-6729f409031c2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ROPINIROLEROPINIROLEMajor Pharmaceuticalse7ef58c0-73ba-4af2-b82b-a33954ec44df2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ROPINIROLEROPINIROLEAlembic Pharmaceuticals Limited9a25f575-09ab-4d32-b73e-5426f08c00c42025-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ROPINIROLEROPINIROLEAlembic Pharmaceuticals Inc.6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c2025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEBryant Ranch Prepack3b8bb729-e084-4d45-9774-63cae192be322025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ROPINIROLEROPINIROLECoupler LLC2cd9b1e8-5856-4b79-e063-6394a90ab2602025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ROPINIROLEROPINIROLECoupler LLC2cdae415-479b-c14c-e063-6394a90adb6c2025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs48a63d7e-c0af-4b09-863c-2af7beb2e80f2024-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEBryant Ranch Prepack00c0ab77-914a-4e8a-bcb7-24cecacfebb12024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-780-906191907809030 TABLET, FILM COATED in 1 BOTTLE (61919-780-90) 2019-01-140000-00-00NoNoCurrent