Ropinirole

Product NDC
69452-362
11-digit product format
694520362
Labeler code
69452
Product ID
69452-362_4fb684db-c9c7-f5a9-e063-6394a90a0931
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA079229
Marketing category
ANDA
Marketing start
2022-09-15
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
5 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 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
A079229-001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2012-11-28
A079229-002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2012-11-28
A079229-003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2012-11-28
A079229-004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28
A079229-005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2012-11-28
A079229-006ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28
A079229-007ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2012-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079229-001AB
A079229-002AB
A079229-003AB
A079229-004AB
A079229-005AB
A079229-006AB
A079229-007AB

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 UTC2026-02A079229-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2012-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079229-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2012-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079229-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2012-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079229-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079229-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2012-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079229-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079229-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2012-11-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079229-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2012-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079229-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2012-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079229-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2012-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079229-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079229-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2012-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079229-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079229-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2012-11-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A079229-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2012-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079229-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2012-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079229-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2012-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079229-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079229-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2012-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079229-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079229-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2012-11-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079229-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2012-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079229-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2012-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079229-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2012-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079229-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079229-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2012-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079229-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079229-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2012-11-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079229-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2012-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079229-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2012-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079229-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2012-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079229-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079229-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2012-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079229-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079229-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2012-11-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079229-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2012-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079229-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2012-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079229-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2012-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079229-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079229-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2012-11-2803ed91905a0d…

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 UTC2026-02A079229-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079229-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079229-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079229-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079229-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079229-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079229-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079229-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079229-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079229-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079229-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079229-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079229-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079229-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079229-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079229-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079229-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079229-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079229-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079229-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079229-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079229-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079229-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079229-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079229-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079229-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079229-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079229-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079229-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079229-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079229-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079229-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079229-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079229-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079229-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079229-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079229-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079229-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079229-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079229-005AB103ed91905a0d…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE5 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 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283858Internal RxNorm lookup
312845Internal RxNorm lookup
312846Internal RxNorm lookup
312847Internal RxNorm lookup
312849Internal RxNorm lookup
314208Internal RxNorm lookup
562704Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e6b070c-50a6-4742-af3c-59b45c45735eAvailable 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
69452-362-20Ropinirole100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-362-20EA - Each69452-362ee07dda6-da8c-4acc-a541-16430e47368512023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-362ROPINIROLE TABLET, FILM COATED [BIONPHARMA INC.]3Current NDC, Legacy NDC, 1 package rows20231211_4e6b070c-50a6-4742-af3c-59b45c45735e.zip

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
RopiniroleROPINIROLEBryant Ranch Prepacke9ba4108-7095-4771-840e-bf1e08b5f4da2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079229
application number: ANDA079229
RopiniroleROPINIROLEBryant Ranch Prepackeaca095f-198b-4c00-812b-1777bf2fc6a92026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079229
application number: ANDA079229
RopiniroleROPINIROLEBryant Ranch Prepack391a1566-09b5-4362-9fbd-5afe4803269f2026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079229
application number: ANDA079229
RopiniroleROPINIROLEBryant Ranch Prepackaf340f28-92b2-49af-b651-b9b01ca3ce6c2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079229
application number: ANDA079229
RopiniroleROPINIROLEASCLEMED USA INC.8f3612f0-0976-4de7-a1d6-eabaa8b75f9c2026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079229
application number: ANDA079229
RopiniroleROPINIROLEBionpharma Inc.4e6b070c-50a6-4742-af3c-59b45c45735e2026-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079229
application number: ANDA079229
ndc (product): 69452-362
RopiniroleROPINIROLEBryant Ranch Prepack245fc49d-609e-4431-b8fa-668b39d12ec22026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079229
application number: ANDA079229
RopiniroleROPINIROLEREMEDYREPACK INC.cdc63b7a-062a-4519-a63e-e48a356f641c2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079229
application number: ANDA079229
RopiniroleROPINIROLEDirect_Rxfebd4b37-6039-5522-e053-6394a90a855f2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079229
application number: ANDA079229
RopiniroleROPINIROLEA-S Medication Solutions339a961e-4eb0-4406-913e-ccc9e9bde0842024-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079229
application number: ANDA079229

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN4e6b070c-50a6-4742-af3c-59b45c45735e6
312846rOPINIRole HCl 0.5 MG Oral TabletPSN4e6b070c-50a6-4742-af3c-59b45c45735e6
314208rOPINIRole HCl 1 MG Oral TabletPSN4e6b070c-50a6-4742-af3c-59b45c45735e6
312847rOPINIRole HCl 2 MG Oral TabletPSN4e6b070c-50a6-4742-af3c-59b45c45735e6
283858rOPINIRole HCl 3 MG Oral TabletPSN4e6b070c-50a6-4742-af3c-59b45c45735e6
562704rOPINIRole HCl 4 MG Oral TabletPSN4e6b070c-50a6-4742-af3c-59b45c45735e6
312849rOPINIRole HCl 5 MG Oral TabletPSN4e6b070c-50a6-4742-af3c-59b45c45735e6
312845ropinirole 0.25 MG Oral TabletSCD4e6b070c-50a6-4742-af3c-59b45c45735e6
312846ropinirole 0.5 MG Oral TabletSCD4e6b070c-50a6-4742-af3c-59b45c45735e6
314208ropinirole 1 MG Oral TabletSCD4e6b070c-50a6-4742-af3c-59b45c45735e6
312847ropinirole 2 MG Oral TabletSCD4e6b070c-50a6-4742-af3c-59b45c45735e6
283858ropinirole 3 MG Oral TabletSCD4e6b070c-50a6-4742-af3c-59b45c45735e6
562704ropinirole 4 MG Oral TabletSCD4e6b070c-50a6-4742-af3c-59b45c45735e6
312849ropinirole 5 MG Oral TabletSCD4e6b070c-50a6-4742-af3c-59b45c45735e6
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY4e6b070c-50a6-4742-af3c-59b45c45735e6
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY4e6b070c-50a6-4742-af3c-59b45c45735e6
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY4e6b070c-50a6-4742-af3c-59b45c45735e6
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY4e6b070c-50a6-4742-af3c-59b45c45735e6
283858ropinirole 3 MG (as ropinirole hydrochloride) Oral TabletSY4e6b070c-50a6-4742-af3c-59b45c45735e6
562704ropinirole 4 MG (as ropinirole hydrochloride) Oral TabletSY4e6b070c-50a6-4742-af3c-59b45c45735e6
312849ropinirole 5 MG (as ropinirole hydrochloride) Oral TabletSY4e6b070c-50a6-4742-af3c-59b45c45735e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69452-362-2069452036220100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-362-20) 2022-09-150000-00-00NoNoCurrent