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 .25 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4803
Product ID 50090-4803_964359dc-018a-469d-a2e6-cf5191a4b2ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204022
Listing Expiration 2026-12-31
Marketing Start 2018-10-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500904803
Hyphenated Format 50090-4803

Supplemental Identifiers

RxCUI
312845
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 ANDA204022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (50090-4803-0)
source: ndc

Packages (1)

50090-4803-0 100 TABLET, FILM COATED in 1 BOTTLE (50090-4803-0)

Ingredients (1)

ropinirole hydrochloride (.25 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": "964359dc-018a-469d-a2e6-cf5191a4b2ec", "openfda": {"unii": ["D7ZD41RZI9"], "rxcui": ["312845"], "spl_set_id": ["4f4729f8-c910-4a09-a4b4-b4243e7f0105"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (50090-4803-0)", "package_ndc": "50090-4803-0", "marketing_start_date": "20191220"}], "brand_name": "ropinirole", "product_id": "50090-4803_964359dc-018a-469d-a2e6-cf5191a4b2ec", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "50090-4803", "generic_name": "ropinirole", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ropinirole", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": ".25 mg/1"}], "application_number": "ANDA204022", "marketing_category": "ANDA", "marketing_start_date": "20181017", "listing_expiration_date": "20261231"}