Home NDC 55648-172 Ropinirole Hydrochloride
Product NDC 55648-172
11-digit product format 556480172
Labeler code 55648
Product ID 55648-172_04e661d1-6156-43d0-abbd-64be8eca1666
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ropinirole Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wockhardt Limited
Application ANDA079050
Marketing category ANDA
Marketing start 2008-05-29
Marketing end 0000-00-00
Substance ROPINIROLE HYDROCHLORIDE
Active strength 2 mg/1
Pharmacologic classes Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag E
Listing certified through 2018-12-31
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 2 · 110 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A079050-001 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2008-05-29 A079050-002 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2008-05-29 A079050-003 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-05-29 A079050-004 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2008-05-29 A079050-005 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2008-05-29 A079050-006 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2008-05-29 A079050-007 ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-05-29
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 A079050-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2008-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079050-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2008-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079050-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079050-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2008-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079050-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2008-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079050-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2008-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079050-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-05-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079050-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2008-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079050-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2008-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079050-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079050-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2008-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079050-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2008-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079050-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2008-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079050-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-05-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079050-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2008-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079050-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2008-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079050-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079050-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2008-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079050-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2008-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079050-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2008-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079050-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079050-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2008-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079050-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2008-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079050-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079050-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2008-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079050-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2008-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079050-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2008-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079050-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079050-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2008-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079050-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2008-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079050-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079050-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2008-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079050-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2008-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079050-006 ROPINIROLE HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL AB 2008-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079050-007 ROPINIROLE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079050-001 ROPINIROLE HYDROCHLORIDE EQ 0.25MG BASE TABLET / ORAL AB 2008-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079050-002 ROPINIROLE HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2008-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079050-003 ROPINIROLE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2008-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079050-004 ROPINIROLE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2008-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079050-005 ROPINIROLE HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2008-05-29 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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55648-172-01 Ropinirole Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 2 55648-172-02 Ropinirole Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 2 55648-172-03 Ropinirole Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 2 55648-172-04 Ropinirole Hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 2 55648-172-04 Ropinirole Hydrochloride 10 in 1 CARTON TABLET, FILM COATED 10 2
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 [WOCKHARDT LIMITED] 2 ROPINIROLE ACTIVE MOIETY 030PYR8953 ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 CARMINIC ACID INACTIVE INGREDIENT CID8Z8N95N ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55648-172 ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 Legacy NDC, 5 package rows 20130307_414cd6c4-4926-4dfc-93c4-f04f4b7eeac3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 55648-172-01 55648017201 30 in 1 BOTTLE Historical 55648-172-02 55648017202 100 in 1 BOTTLE Historical 55648-172-03 55648017203 500 in 1 BOTTLE Historical 55648-172-04 55648017204 10 in 1 BLISTER PACK Historical