Ropinirole

Product NDC
13811-641
Requested package NDC
13811-641-50
11-digit product format
138110641
Labeler code
13811
Product ID
13811-641_4d6c8925-b701-4ab9-bd50-a83c999cb157
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropinirole
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Trigen Laboratories, LLC
Application
ANDA202786
Marketing category
ANDA
Marketing start
2013-03-14
Marketing end
2021-02-28
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
6 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage13811-64113811-641-50DDiscontinued by firm2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202786-001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22
A202786-002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22
A202786-003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22
A202786-004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22
A202786-005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A202786-001AB
A202786-002AB
A202786-003AB
A202786-004AB
A202786-005AB

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202786-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202786-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202786-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202786-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202786-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202786-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202786-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202786-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202786-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202786-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A202786-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202786-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202786-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202786-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202786-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202786-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202786-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202786-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202786-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202786-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202786-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202786-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202786-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202786-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202786-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202786-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202786-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202786-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202786-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202786-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202786-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202786-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202786-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202786-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202786-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202786-001ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202786-002ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202786-003ROPINIROLE HYDROCHLORIDEEQ 6MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202786-004ROPINIROLE HYDROCHLORIDEEQ 8MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202786-005ROPINIROLE HYDROCHLORIDEEQ 12MG BASETABLET, EXTENDED RELEASE / ORALAB2013-04-225bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202786-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202786-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202786-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202786-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202786-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202786-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202786-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202786-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202786-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202786-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202786-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202786-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202786-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202786-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202786-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202786-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202786-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202786-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202786-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202786-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202786-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202786-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202786-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202786-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202786-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202786-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202786-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202786-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202786-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202786-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202786-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202786-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202786-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202786-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202786-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202786-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202786-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202786-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202786-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202786-005AB15bbf6a4d5a75…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-641-30EA - Each13811-6414a36852f-d339-4d0e-8b38-6a3410ed85a212013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311ROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
TALCINACTIVE INGREDIENT7SEV7J4R1UROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RopiniroleROPINIROLEAlembic Pharmaceuticals Inc.54fb15b7-da35-4841-ba5d-ee3712cd94f32024-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202786
application number: ANDA202786
RopiniroleROPINIROLEAlembic Pharmaceuticals Limited2e01dbdd-f439-45d7-9085-2d92a1a1fee22023-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202786
application number: ANDA202786

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13811-641-5013811064150500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (13811-641-50) 2013-03-142021-02-28NoNoCurrent