Home NDC 10135-674 Ropinirole
Product NDC 10135-674
11-digit product format 101350674
Labeler code 10135
Product ID 10135-674_441e0572-3413-1a21-e063-6294a90a8e6a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ropinirole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Marlex Pharmaceuticals Inc
Application ANDA079165
Marketing category ANDA
Marketing start 2019-03-15
Substance ROPINIROLE HYDROCHLORIDE
Active strength .5 mg/1
Pharmacologic classes Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A079165-001 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2012-02-07 A079165-002 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2012-02-07 A079165-003 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2012-02-07 A079165-004 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2012-02-07 A079165-005 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2012-02-07 A079165-006 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2012-02-07 A079165-007 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-02-07
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 · 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 A079165-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2012-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079165-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2012-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079165-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2012-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079165-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2012-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079165-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2012-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079165-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2012-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079165-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079165-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2012-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079165-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2012-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079165-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2012-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079165-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2012-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079165-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2012-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079165-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2012-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079165-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079165-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2012-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079165-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2012-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079165-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2012-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079165-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2012-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079165-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2012-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079165-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2012-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079165-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079165-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2012-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079165-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2012-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079165-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2012-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079165-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2012-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079165-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2012-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079165-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2012-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079165-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079165-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2012-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079165-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2012-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079165-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2012-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079165-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2012-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079165-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2012-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079165-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2012-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079165-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079165-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2012-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079165-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2012-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079165-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2012-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079165-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2012-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079165-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2012-02-07 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 287 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ropinirole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ROPINIROLE HYDROCHLORIDE .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D7ZD41RZI9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 7 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283858 Internal RxNorm lookup 312845 Internal RxNorm lookup 312846 Internal RxNorm lookup 312847 Internal RxNorm lookup 312849 Internal RxNorm lookup 314208 Internal RxNorm lookup 562704 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10135-674-01 Ropinirole 100 in 1 BOTTLE TABLET, FILM COATED 100 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-674 ROPINIROLE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC] 9 Current NDC, Legacy NDC, 1 package rows 20241019_35d90f6f-3116-4afa-be2d-b65c160e8ab3.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 10135-674-01 10135067401 100 TABLET, FILM COATED in 1 BOTTLE (10135-674-01) 2019-03-15 0000-00-00 No No Current