Ropinirole

Product NDC
72189-416
11-digit product format
721890416
Labeler code
72189
Product ID
72189-416_2c4cfec2-fee0-e007-e063-6294a90a3cf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090135
Marketing category
ANDA
Marketing start
2023-02-01
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
.25 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct72189-416UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-41672189-416-30UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct72189-416UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-41672189-416-30UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
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 · 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 UTC2026-02A090135-001ROPINIROLE 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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090135-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090135-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-02-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090135-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-02-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090135-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-02-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090135-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-02-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090135-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-02-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090135-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-02-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090135-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-02-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090135-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-02-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090135-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-02-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090135-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-02-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090135-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-02-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090135-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-02-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090135-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-02-2503ed91905a0d…

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 UTC2026-02A090135-001AB1011fe1cb6892…
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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090135-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090135-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090135-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090135-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090135-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090135-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090135-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090135-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090135-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090135-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090135-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090135-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090135-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090135-005AB103ed91905a0d…

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
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
ndc (product): 72189-416

Additional Listing Data#

Finished product
Yes
Brand name base
Ropinirole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE.25 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
312845Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3a9982a-015a-1134-e053-2a95a90ad2d4Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-416-30Ropinirole30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-416-30EA - Each72189-416f143aacd-93e6-45e7-b8b9-8a72bdab31a512023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-416ROPINIROLE TABLET, FILM COATED [DIRECT_RX]2Current NDC, 1 package rows20250123_f3a9982a-015a-1134-e053-2a95a90ad2d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSNf3a9982a-015a-1134-e053-2a95a90ad2d42
312845ropinirole 0.25 MG Oral TabletSCDf3a9982a-015a-1134-e053-2a95a90ad2d42
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSYf3a9982a-015a-1134-e053-2a95a90ad2d42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-416-307218904163030 TABLET, FILM COATED in 1 BOTTLE (72189-416-30) 2023-02-01NoNoCurrent