Home NDC 63629-3760 REQUIP
Product NDC 63629-3760
11-digit product format 636293760
Labeler code 63629
Product ID 63629-3760_14c4c4ff-913b-4d12-a617-450cf58ca0bb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ropinirole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA020658
Marketing category NDA
Marketing start 1997-10-01
Marketing end 0000-00-00
Substance ROPINIROLE HYDROCHLORIDE
Active strength 1 mg/1
Pharmacologic classes Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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REQUIP ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 N020658-002 REQUIP ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 N020658-003 REQUIP ROPINIROLE HYDROCHLORIDE EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 N020658-004 REQUIP ROPINIROLE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 N020658-005 REQUIP ROPINIROLE HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-19 N020658-006 REQUIP ROPINIROLE HYDROCHLORIDE EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-01-27 N020658-007 REQUIP ROPINIROLE HYDROCHLORIDE EQ 4MG BASE **Federal Register determination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.