ropinirole

Product NDC
68788-4138
11-digit product format
687884138
Labeler code
68788
Product ID
68788-4138_0030ffac-183a-472c-95b8-f93b4195de04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090135
Marketing category
ANDA
Marketing start
2026-07-06
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090135-001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-02-25
A090135-002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-02-25
A090135-003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-02-25
A090135-004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-02-25
A090135-005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-02-25
A090135-006ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-02-25
A090135-007ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090135-001AB
A090135-002AB
A090135-003AB
A090135-004AB
A090135-005AB
A090135-006AB
A090135-007AB

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 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090135-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-02-2584e616aacf4f…
2026-09-14 22:38:342026-08A090135-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-02-2584e616aacf4f…
2026-09-14 22:38:342026-08A090135-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-02-2584e616aacf4f…
2026-09-14 22:38:342026-08A090135-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-02-2584e616aacf4f…
2026-09-14 22:38:342026-08A090135-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-02-2584e616aacf4f…
2026-09-14 22:38:342026-08A090135-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-02-2584e616aacf4f…
2026-09-14 22:38:342026-08A090135-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-02-2584e616aacf4f…
2026-08-18 06:07:402026-07A090135-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090135-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090135-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090135-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090135-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090135-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090135-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-02-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090135-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090135-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090135-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090135-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090135-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090135-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090135-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-02-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090135-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090135-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090135-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090135-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090135-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090135-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090135-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-02-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090135-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090135-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090135-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090135-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090135-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090135-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090135-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-02-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090135-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090135-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090135-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090135-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090135-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-02-25fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090135-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090135-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090135-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A090135-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A090135-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A090135-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A090135-007AB184e616aacf4f…
2026-08-18 06:07:402026-07A090135-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090135-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090135-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090135-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090135-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090135-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090135-007AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090135-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090135-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090135-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090135-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090135-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090135-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090135-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090135-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090135-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090135-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090135-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090135-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090135-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090135-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090135-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090135-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090135-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090135-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090135-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090135-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090135-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090135-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090135-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090135-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090135-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090135-005AB1fd3edfee7708…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
ropinirole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D7ZD41RZI9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312847Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0030ffac-183a-472c-95b8-f93b4195de04Available on FDA.report

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ropiniroleROPINIROLEPreferred Pharmaceuticals Inc.0030ffac-183a-472c-95b8-f93b4195de042026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090135
application number: ANDA090135
ndc (product): 68788-4138
ropiniroleROPINIROLEREMEDYREPACK INC.594081d7-2e03-4780-bdc2-bb5361839f2a2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090135
application number: ANDA090135
ropiniroleROPINIROLEBryant Ranch Prepackc89f68e5-d2ad-4aad-a63c-c32eff5e82c92026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090135
application number: ANDA090135
ropiniroleROPINIROLEBryant Ranch Prepacke32ef7a6-b4b6-4a22-a2ed-722255b486b42026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090135
application number: ANDA090135
ropiniroleROPINIROLEREMEDYREPACK INC.864b38b0-1d4b-4da8-9645-c1760a2080ce2026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090135
application number: ANDA090135
ropiniroleROPINIROLEREMEDYREPACK INC.16752e1b-10eb-4c31-92d4-ff6c6e8466f42026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090135
application number: ANDA090135
ropiniroleROPINIROLEA-S Medication Solutions35d0074e-212b-4a1f-9cd7-974ca08d2c952026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090135
application number: ANDA090135
ropiniroleROPINIROLEGlenmark Pharmaceuticals Inc., USA85971b31-6f7d-421c-bf3c-5b33f3c1e7812026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090135
application number: ANDA090135
ropiniroleROPINIROLEA-S Medication Solutionsba358e45-09ab-46ed-986b-67affeb240a42025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090135
application number: ANDA090135
RopiniroleROPINIROLEDirect_Rxf3a9982a-015a-1134-e053-2a95a90ad2d42025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090135
application number: ANDA090135

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4138-36878841380330 TABLET, FILM COATED in 1 BOTTLE (68788-4138-3) 2026-07-06NoNoCurrent