ropinirole hydrochloride

Product NDC
50268-744
11-digit product format
502680744
Labeler code
50268
Product ID
50268-744_2b4c1c97-dc70-3801-e063-6394a90a7faf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA078110
Marketing category
ANDA
Marketing start
2022-08-19
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
2 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

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
A078110-001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALABRS2008-05-05
A078110-002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-05
A078110-003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-05
A078110-004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-05
A078110-005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-05
A078110-006ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2008-05-05
A078110-007ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2008-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078110-001AB
A078110-002AB
A078110-003AB
A078110-004AB
A078110-005AB
A078110-006AB
A078110-007AB

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 UTC2026-02A078110-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALABRS2008-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078110-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078110-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078110-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078110-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078110-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2008-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078110-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2008-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078110-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALABRS2008-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078110-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078110-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078110-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078110-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078110-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2008-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078110-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2008-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078110-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALABRS2008-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078110-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078110-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078110-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078110-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078110-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2008-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078110-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2008-07-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078110-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALABRS2008-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078110-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078110-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078110-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078110-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078110-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2008-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078110-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2008-07-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078110-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALABRS2008-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078110-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078110-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078110-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078110-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078110-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2008-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078110-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2008-07-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078110-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALABRS2008-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078110-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078110-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078110-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078110-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-0503ed91905a0d…

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 UTC2026-02A078110-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078110-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078110-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078110-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078110-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078110-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078110-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078110-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078110-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078110-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078110-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078110-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078110-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078110-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078110-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078110-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078110-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078110-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078110-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078110-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078110-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078110-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078110-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078110-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078110-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078110-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078110-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078110-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078110-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078110-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078110-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078110-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078110-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078110-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078110-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078110-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078110-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078110-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078110-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078110-005AB103ed91905a0d…

Additional Listing Data#

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

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 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e699a31a-25fc-554b-e053-2a95a90a843aAvailable 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
50268-744-11ropinirole hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED12
50268-744-15ropinirole hydrochloride50 in 1 BOXTABLET, FILM COATED502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-744-11EA - Each50268-744ce819b1f-0c07-4a5a-b6df-afd63d0fc0de12022-09-12
50268-744-15EA - Each50268-744b6d5833e-ed62-44c3-804b-e131c3bc625612022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-744ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [AVPAK]2Current NDC, Legacy NDC, 2 package rows20250112_e699a31a-25fc-554b-e053-2a95a90a843a.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEA-S Medication Solutionsa97d5e2d-4a17-4d80-9216-1b07801995022026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDENorthwind Health Company, LLCab6d21b6-2584-4b97-e053-2a95a90adc502026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDESOLCO HEALTHCARE US, LLC7734ef0b-584f-42dd-a8b5-adbdf4e4df932025-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDESOLCO HEALTHCARE US, LLC5823b3a2-3256-4d94-97b4-ec6b940312f42025-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEAvPAKe699a31a-25fc-554b-e053-2a95a90a843a2025-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ndc (product): 50268-744
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEAmerican Health Packaging6849b3c0-e36b-4bea-82f2-b33ae3d44c952025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEBryant Ranch Prepack6c10444a-48da-469d-bf8f-1e6e0b7e15f82023-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEProficient Rx LP89e3865c-1fe1-4f29-9606-8830df4bbe532023-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110
ropinirole hydrochlorideROPINIROLE HYDROCHLORIDEA-S Medication Solutions9c4dacc6-cebc-4f42-85fc-41083512b2902023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078110
application number: ANDA078110

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSNe699a31a-25fc-554b-e053-2a95a90a843a2
312846rOPINIRole HCl 0.5 MG Oral TabletPSNe699a31a-25fc-554b-e053-2a95a90a843a2
314208rOPINIRole HCl 1 MG Oral TabletPSNe699a31a-25fc-554b-e053-2a95a90a843a2
312847rOPINIRole HCl 2 MG Oral TabletPSNe699a31a-25fc-554b-e053-2a95a90a843a2
312845ropinirole 0.25 MG Oral TabletSCDe699a31a-25fc-554b-e053-2a95a90a843a2
312846ropinirole 0.5 MG Oral TabletSCDe699a31a-25fc-554b-e053-2a95a90a843a2
314208ropinirole 1 MG Oral TabletSCDe699a31a-25fc-554b-e053-2a95a90a843a2
312847ropinirole 2 MG Oral TabletSCDe699a31a-25fc-554b-e053-2a95a90a843a2
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSYe699a31a-25fc-554b-e053-2a95a90a843a2
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSYe699a31a-25fc-554b-e053-2a95a90a843a2
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSYe699a31a-25fc-554b-e053-2a95a90a843a2
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSYe699a31a-25fc-554b-e053-2a95a90a843a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-744-11502680744111 in 1 BLISTER PACKHistorical
50268-744-155026807441550 BLISTER PACK in 1 BOX (50268-744-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-744-11) 50 blister pack2022-08-190000-00-00NoNoCurrent