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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-3760DDiscontinued by firm2026-08-10
excluded packagepackage63629-376063629-3760-1DDiscontinued by firm2026-08-10
excluded packagepackage63629-376063629-3760-2DDiscontinued 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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3760-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3760-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3760-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3760-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3760-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3760-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3760-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3760-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3760-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3760-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3760-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3760-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3760-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3760-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3760-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3760-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3760-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3760-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-3760-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-3760-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-3760-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-3760-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-3760-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-3760-1557ba5c1ecfa…9c80585c8c6e…

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
N020658-001REQUIPROPINIROLE HYDROCHLORIDEEQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19
N020658-002REQUIPROPINIROLE HYDROCHLORIDEEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19
N020658-003REQUIPROPINIROLE HYDROCHLORIDEEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19
N020658-004REQUIPROPINIROLE HYDROCHLORIDEEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19
N020658-005REQUIPROPINIROLE HYDROCHLORIDEEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19
N020658-006REQUIPROPINIROLE HYDROCHLORIDEEQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-27
N020658-007REQUIPROPINIROLE HYDROCHLORIDEEQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-27

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 · 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 UTC2026-02N020658-001REQUIPEQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020658-002REQUIPEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020658-003REQUIPEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020658-004REQUIPEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020658-005REQUIPEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020658-006REQUIPEQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020658-007REQUIPEQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020658-001REQUIPEQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020658-002REQUIPEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020658-003REQUIPEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020658-004REQUIPEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020658-005REQUIPEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020658-006REQUIPEQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020658-007REQUIPEQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020658-001REQUIPEQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020658-002REQUIPEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020658-003REQUIPEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020658-004REQUIPEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020658-005REQUIPEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020658-006REQUIPEQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020658-007REQUIPEQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020658-001REQUIPEQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020658-002REQUIPEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020658-003REQUIPEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020658-004REQUIPEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020658-005REQUIPEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020658-006REQUIPEQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020658-007REQUIPEQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020658-001REQUIPEQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020658-002REQUIPEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020658-003REQUIPEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020658-004REQUIPEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020658-005REQUIPEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020658-006REQUIPEQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020658-007REQUIPEQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020658-001REQUIPEQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020658-002REQUIPEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020658-003REQUIPEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020658-004REQUIPEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020658-005REQUIPEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1997-09-1903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N020658-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020658-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020658-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020658-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020658-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020658-006AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020658-007AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020658-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020658-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020658-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020658-004AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020658-005AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020658-006AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020658-007AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020658-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020658-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020658-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020658-004AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020658-005AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020658-006AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020658-007AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020658-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020658-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020658-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020658-004AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020658-005AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020658-006AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020658-007AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020658-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020658-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020658-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020658-004AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020658-005AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020658-006AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020658-007AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020658-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020658-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020658-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020658-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020658-005AB13f01610625f2…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3760-1EA - Each63629-376066d0f02c-6c98-4e10-899d-41c36cac040912013-02-13
63629-3760-2EA - Each63629-3760ce7d181a-9534-4bc1-b414-1c8648913e5312013-02-13