ropinirole

Generic: ropinirole

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropinirole
Generic Name ropinirole
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ropinirole hydrochloride 1 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4684
Product ID 50090-4684_51031fe5-ffc7-4c4c-913f-d94cbb674c65
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090135
Listing Expiration 2026-12-31
Marketing Start 2010-02-25

Pharmacologic Class

Classes
dopamine agonists [moa] nonergot dopamine agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500904684
Hyphenated Format 50090-4684

Supplemental Identifiers

RxCUI
314208
UNII
D7ZD41RZI9

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ropinirole (source: ndc)
Generic Name ropinirole (source: ndc)
Application Number ANDA090135 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-4684-0)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-4684-1)
source: ndc

Packages (2)

50090-4684-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-4684-0) 50090-4684-1 90 TABLET, FILM COATED in 1 BOTTLE (50090-4684-1)

Ingredients (1)

ropinirole hydrochloride (1 mg/1)

Linked Drug Pages (1)

ropinirole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "51031fe5-ffc7-4c4c-913f-d94cbb674c65", "openfda": {"unii": ["D7ZD41RZI9"], "rxcui": ["314208"], "spl_set_id": ["ba358e45-09ab-46ed-986b-67affeb240a4"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-4684-0)", "package_ndc": "50090-4684-0", "marketing_start_date": "20191105"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-4684-1)", "package_ndc": "50090-4684-1", "marketing_start_date": "20191105"}], "brand_name": "ropinirole", "product_id": "50090-4684_51031fe5-ffc7-4c4c-913f-d94cbb674c65", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "50090-4684", "generic_name": "ropinirole", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ropinirole", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA090135", "marketing_category": "ANDA", "marketing_start_date": "20100225", "listing_expiration_date": "20261231"}