Home NDC 0007-4891 REQUIP
Product NDC 0007-4891
11-digit product format 000074891
Labeler code 0007
Product ID 0007-4891_1f8d4972-d7e0-4f31-a10c-6ff0936047b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ropinirole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler GlaxoSmithKline LLC
Application NDA020658
Marketing category NDA
Marketing start 1997-10-10
Marketing end 2019-11-30
Substance ROPINIROLE HYDROCHLORIDE
Active strength 1 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 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0007-4891-20 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0007-4891-20 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0007-4891-20 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0007-4891-20 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0007-4891-20 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0007-4891-20 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0007-4891-20 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0007-4891-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0007-4891-20 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0007-4891-20 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0007-4891-20 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0007-4891-20 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020658-001 REQUIP ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 N020658-002 REQUIP ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 N020658-003 REQUIP ROPINIROLE HYDROCHLORIDE EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 N020658-004 REQUIP ROPINIROLE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 N020658-005 REQUIP ROPINIROLE HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 N020658-006 REQUIP ROPINIROLE HYDROCHLORIDE EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-01-27 N020658-007 REQUIP ROPINIROLE HYDROCHLORIDE EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-01-27
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 · 308 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N020658-001 REQUIP EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020658-002 REQUIP EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020658-003 REQUIP EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020658-004 REQUIP EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020658-005 REQUIP EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020658-006 REQUIP EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-01-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020658-007 REQUIP EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-01-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 N020658-001 REQUIP EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020658-002 REQUIP EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020658-003 REQUIP EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020658-004 REQUIP EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020658-005 REQUIP EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020658-006 REQUIP EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020658-007 REQUIP EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-01-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020658-001 REQUIP EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020658-002 REQUIP EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020658-003 REQUIP EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020658-004 REQUIP EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020658-005 REQUIP EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020658-006 REQUIP EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020658-007 REQUIP EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-01-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020658-001 REQUIP EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020658-002 REQUIP EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020658-003 REQUIP EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020658-004 REQUIP EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020658-005 REQUIP EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020658-006 REQUIP EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020658-007 REQUIP EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020658-001 REQUIP EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020658-002 REQUIP EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020658-003 REQUIP EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020658-004 REQUIP EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020658-005 REQUIP EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020658-006 REQUIP EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020658-007 REQUIP EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020658-001 REQUIP EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020658-002 REQUIP EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020658-003 REQUIP EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020658-004 REQUIP EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020658-005 REQUIP EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 56 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ROPINIROLE HYDROCHLORIDE ACTIVE INGREDIENT D7ZD41RZI9 REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 ROPINIROLE ACTIVE MOIETY 030PYR8953 REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 COCHINEAL INACTIVE INGREDIENT TZ8Z31B35M REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 9