Ropinirole

Product NDC
46708-264
11-digit product format
467080264
Labeler code
46708
Product ID
46708-264_a1e5da4e-74fc-4482-8e15-599c665f2c2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropinirole
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA202786
Marketing category
ANDA
Marketing start
2013-03-14
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
6 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 · 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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE6 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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
799054Internal RxNorm lookup
799055Internal RxNorm lookup
799056Internal RxNorm lookup
824959Internal RxNorm lookup
848582Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2e01dbdd-f439-45d7-9085-2d92a1a1fee2Available 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
46708-264-10Ropinirole100 in 1 CARTONTABLET, FILM COATED, EXTENDED RE1004
46708-264-30Ropinirole30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE304
46708-264-31Ropinirole100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1004
46708-264-71Ropinirole500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5004
46708-264-90Ropinirole90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE904
46708-264-91Ropinirole1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-264ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 6 package rows20230129_2e01dbdd-f439-45d7-9085-2d92a1a1fee2.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 · 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
ndc (product): 46708-264

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
824959rOPINIRole 12 MG 24HR Extended Release Oral TabletPSN2e01dbdd-f439-45d7-9085-2d92a1a1fee24
799055rOPINIRole 2 MG 24HR Extended Release Oral TabletPSN2e01dbdd-f439-45d7-9085-2d92a1a1fee24
799056rOPINIRole 4 MG 24HR Extended Release Oral TabletPSN2e01dbdd-f439-45d7-9085-2d92a1a1fee24
848582rOPINIRole 6 MG 24HR Extended Release Oral TabletPSN2e01dbdd-f439-45d7-9085-2d92a1a1fee24
799054rOPINIRole 8 MG 24HR Extended Release Oral TabletPSN2e01dbdd-f439-45d7-9085-2d92a1a1fee24
82495924 HR ropinirole 12 MG Extended Release Oral TabletSCD2e01dbdd-f439-45d7-9085-2d92a1a1fee24
79905524 HR ropinirole 2 MG Extended Release Oral TabletSCD2e01dbdd-f439-45d7-9085-2d92a1a1fee24
79905624 HR ropinirole 4 MG Extended Release Oral TabletSCD2e01dbdd-f439-45d7-9085-2d92a1a1fee24
84858224 HR ropinirole 6 MG Extended Release Oral TabletSCD2e01dbdd-f439-45d7-9085-2d92a1a1fee24
79905424 HR ropinirole 8 MG Extended Release Oral TabletSCD2e01dbdd-f439-45d7-9085-2d92a1a1fee24
824959ropinirole 12 MG (as ropinirole hydrochloride 13.68 MG) 24 HR Extended Release Oral TabletSY2e01dbdd-f439-45d7-9085-2d92a1a1fee24
824959ropinirole 12 MG 24 HR Extended Release Oral TabletSY2e01dbdd-f439-45d7-9085-2d92a1a1fee24
799055ropinirole 2 MG (as ropinirole hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY2e01dbdd-f439-45d7-9085-2d92a1a1fee24
799055ropinirole 2 MG 24 HR Extended Release Oral TabletSY2e01dbdd-f439-45d7-9085-2d92a1a1fee24
799056ropinirole 4 MG (as ropinirole hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY2e01dbdd-f439-45d7-9085-2d92a1a1fee24
799056ropinirole 4 MG 24 HR Extended Release Oral TabletSY2e01dbdd-f439-45d7-9085-2d92a1a1fee24
848582ropinirole 6 MG (ropinirole hydrochloride 6.84 MG) 24 HR Extended Release Oral TabletSY2e01dbdd-f439-45d7-9085-2d92a1a1fee24
848582ropinirole 6 MG 24 HR Extended Release Oral TabletSY2e01dbdd-f439-45d7-9085-2d92a1a1fee24
799054ropinirole 8 MG (as ropinirole hydrochloride 9.12 MG) 24 HR Extended Release Oral TabletSY2e01dbdd-f439-45d7-9085-2d92a1a1fee24
799054ropinirole 8 MG 24 HR Extended Release Oral TabletSY2e01dbdd-f439-45d7-9085-2d92a1a1fee24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-264-1046708026410100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (46708-264-10) 2013-03-140000-00-00NoNoCurrent
46708-264-304670802643030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-30) 2013-03-140000-00-00NoNoCurrent
46708-264-3146708026431100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-31) 2013-03-140000-00-00NoNoCurrent
46708-264-7146708026471500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-71) 2013-03-140000-00-00NoNoCurrent
46708-264-904670802649090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-90) 2013-03-140000-00-00NoNoCurrent
46708-264-91467080264911000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-91) 2013-03-140000-00-00NoNoCurrent