ropinirole hydrochloride

Product NDC
50090-4348
11-digit product format
500904348
Labeler code
50090
Product ID
50090-4348_ca664513-9e1f-45df-8d3b-e649191dd90d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078110
Marketing category
ANDA
Marketing start
2011-09-20
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
1 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

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-4348-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-4348-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4348-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4348-1f5e01cc5f278…a2eaf40c39c3…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE1 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
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
a97d5e2d-4a17-4d80-9216-1b0780199502Available 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
50090-4348-0ropinirole hydrochloride30 in 1 BOTTLETABLET, FILM COATED3014
50090-4348-1ropinirole hydrochloride90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4348-1EA - Each50090-43481b042cfe-4e39-4d4a-b1bd-fc1fd6879e5712022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4348ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20231216_a97d5e2d-4a17-4d80-9216-1b0780199502.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
ndc (product): 50090-4348
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
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
314208rOPINIRole HCl 1 MG Oral TabletPSNa97d5e2d-4a17-4d80-9216-1b078019950214
314208ropinirole 1 MG Oral TabletSCDa97d5e2d-4a17-4d80-9216-1b078019950214
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSYa97d5e2d-4a17-4d80-9216-1b078019950214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4348-05009043480030 TABLET, FILM COATED in 1 BOTTLE (50090-4348-0) 2019-06-110000-00-00NoNoCurrent
50090-4348-15009043480190 TABLET, FILM COATED in 1 BOTTLE (50090-4348-1) 2019-06-110000-00-00NoNoCurrent