ROPINIROLE HYDROCHLORIDE

Product NDC
0615-8190
11-digit product format
006158190
Labeler code
0615
Product ID
0615-8190_76b08d6e-992e-4f34-b803-7ed84025a75f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPINIROLE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA090429
Marketing category
ANDA
Marketing start
2016-01-29
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
1 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
A090429-001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-03-24
A090429-002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-03-24
A090429-003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-03-24
A090429-004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-03-24
A090429-005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-03-24
A090429-006ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-03-24
A090429-007ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090429-001AB
A090429-002AB
A090429-003AB
A090429-004AB
A090429-005AB
A090429-006AB
A090429-007AB

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 UTC2026-02A090429-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090429-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2010-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2010-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2010-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2010-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2010-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2010-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2010-03-2403ed91905a0d…

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 UTC2026-02A090429-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090429-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090429-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090429-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090429-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090429-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090429-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090429-005AB103ed91905a0d…

Additional Listing Data#

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

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 · 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
48a63d7e-c0af-4b09-863c-2af7beb2e80fAvailable 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
0615-8190-39ROPINIROLE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET, FILM COATED3018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8190ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]18Current NDC, Legacy NDC, 1 package rows20241027_48a63d7e-c0af-4b09-863c-2af7beb2e80f.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
ROPINIROLEROPINIROLECardinal Health 107, LLC7bf874a3-4d45-41ab-9796-6729f409031c2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ROPINIROLEROPINIROLEMajor Pharmaceuticalse7ef58c0-73ba-4af2-b82b-a33954ec44df2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ROPINIROLEROPINIROLEAlembic Pharmaceuticals Limited9a25f575-09ab-4d32-b73e-5426f08c00c42025-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ROPINIROLEROPINIROLEAlembic Pharmaceuticals Inc.6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c2025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEBryant Ranch Prepack3b8bb729-e084-4d45-9774-63cae192be322025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ROPINIROLEROPINIROLECoupler LLC2cd9b1e8-5856-4b79-e063-6394a90ab2602025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ROPINIROLEROPINIROLECoupler LLC2cdae415-479b-c14c-e063-6394a90adb6c2025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs48a63d7e-c0af-4b09-863c-2af7beb2e80f2024-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429
ndc (product): 0615-8190
ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEBryant Ranch Prepack00c0ab77-914a-4e8a-bcb7-24cecacfebb12024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090429
application number: ANDA090429

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312846rOPINIRole HCl 0.5 MG Oral TabletPSN48a63d7e-c0af-4b09-863c-2af7beb2e80f18
314208rOPINIRole HCl 1 MG Oral TabletPSN48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312847rOPINIRole HCl 2 MG Oral TabletPSN48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312845ropinirole 0.25 MG Oral TabletSCD48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312846ropinirole 0.5 MG Oral TabletSCD48a63d7e-c0af-4b09-863c-2af7beb2e80f18
314208ropinirole 1 MG Oral TabletSCD48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312847ropinirole 2 MG Oral TabletSCD48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY48a63d7e-c0af-4b09-863c-2af7beb2e80f18
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY48a63d7e-c0af-4b09-863c-2af7beb2e80f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8190-390061581903930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8190-39) 2018-03-070000-00-00NoNoCurrent