Home NDC 65841-716-01 ropinirole hydrochloride
Product NDC 65841-716
Requested package NDC 65841-716-01
11-digit product format 658410716
Labeler code 65841
Product ID 65841-716_82436c19-cab1-4857-9a7d-9e32e4ba0f72
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ropinirole hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA090411
Marketing category ANDA
Marketing start 2009-09-23
Marketing end 0000-00-00
Substance ROPINIROLE HYDROCHLORIDE
Active strength 3 mg/1
Pharmacologic classes Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 65841-716 65841-716-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 65841-716 65841-716-01 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A090411-001 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2009-06-01 A090411-002 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2009-06-01 A090411-003 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-01 A090411-004 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2009-06-01 A090411-005 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2009-06-01 A090411-006 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2009-06-01 A090411-007 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2009-06-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 matching rows.
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 · 301 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 2026-09-14 22:38:34 2026-08 A090411-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2009-06-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090411-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2009-06-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090411-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090411-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2009-06-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090411-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2009-06-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090411-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2009-06-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090411-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2009-06-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090411-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2009-06-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090411-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2009-06-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090411-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090411-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2009-06-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090411-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2009-06-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090411-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2009-06-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090411-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2009-06-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090411-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2009-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090411-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2009-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090411-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090411-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2009-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090411-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2009-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090411-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2009-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090411-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2009-06-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090411-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2009-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090411-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2009-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090411-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090411-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2009-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090411-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2009-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090411-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2009-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090411-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2009-06-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090411-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2009-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090411-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2009-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090411-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090411-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2009-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090411-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2009-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090411-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2009-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090411-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2009-06-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090411-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2009-06-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090411-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2009-06-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090411-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2009-06-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090411-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2009-06-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090411-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2009-06-01 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 301 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 ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 ROPINIROLE ACTIVE MOIETY 030PYR8953 ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 COCHINEAL INACTIVE INGREDIENT TZ8Z31B35M ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65841-716 ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 7 Legacy NDC 20221109_5525c364-3574-4029-89dc-1efc6d85c03c.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65841-716-01 65841071601 100 TABLET, FILM COATED in 1 BOTTLE (65841-716-01) 2009-09-23 0000-00-00 No No Current