Home NDC 0615-7536 Ropinirole Hydrochloride
Product NDC 0615-7536
11-digit product format 006157536
Labeler code 0615
Product ID 0615-7536_5774cadb-5f61-47a2-95f8-cc73146016de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ropinirole Hydrochloride
Dosage form TABLET
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA078881
Marketing category ANDA
Marketing start 2011-10-27
Marketing end 0000-00-00
Substance ROPINIROLE HYDROCHLORIDE
Active strength 0 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-7536-39 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-7536-39 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-7536-39 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-7536-39 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-7536-39 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-7536-39 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-7536-39 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-7536-39 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-7536-39 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-7536-39 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-7536-39 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-7536-39 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-7536-39 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-7536-39 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-7536-39 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078881-001 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL 2008-05-05 A078881-002 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2008-05-05 A078881-003 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2008-05-05 A078881-004 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2008-05-05 A078881-005 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2008-05-05 A078881-006 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2008-05-05 A078881-007 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2008-05-19
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A078881-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL 2008-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078881-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2008-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078881-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2008-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078881-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2008-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078881-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2008-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078881-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2008-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078881-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2008-05-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078881-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL 2008-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078881-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2008-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078881-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2008-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078881-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2008-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078881-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2008-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078881-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2008-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078881-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2008-05-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078881-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL 2008-05-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078881-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2008-05-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078881-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2008-05-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078881-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2008-05-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078881-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2008-05-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078881-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2008-05-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078881-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2008-05-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078881-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL 2008-05-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078881-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2008-05-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078881-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2008-05-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078881-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2008-05-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078881-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2008-05-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078881-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2008-05-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078881-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2008-05-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078881-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL 2008-05-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078881-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2008-05-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078881-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2008-05-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078881-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2008-05-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078881-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2008-05-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078881-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2008-05-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078881-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL 2008-05-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078881-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL 2008-05-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078881-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2008-05-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078881-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2008-05-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078881-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 2008-05-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078881-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2008-05-05 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ROPINIROLE HYDROCHLORIDE ACTIVE INGREDIENT D7ZD41RZI9 ROPINIROLE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 ROPINIROLE ACTIVE MOIETY 030PYR8953 ROPINIROLE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ROPINIROLE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ROPINIROLE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ROPINIROLE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ROPINIROLE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ROPINIROLE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ROPINIROLE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ROPINIROLE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ROPINIROLE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ROPINIROLE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12