ropinirole

Generic: ropinirole

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropinirole
Generic Name ropinirole
Labeler solco healthcare us, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

ropinirole 2 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-554
Product ID 43547-554_9bbec058-00a5-4353-bd58-426ddb0b2020
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204413
Listing Expiration 2026-12-31
Marketing Start 2022-03-22

Pharmacologic Class

Established (EPC)
nonergot dopamine agonist [epc]
Mechanism of Action
dopamine agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547554
Hyphenated Format 43547-554

Supplemental Identifiers

RxCUI
799054 799055 799056 824959 848582
UPC
0343547554033 0343547557034 0343547556037 0343547555030 0343547558031
UNII
030PYR8953
NUI
N0000000117 N0000175768

Packaging Origin

Original Packager
true

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 ANDA204413 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-554-03)
source: ndc

Packages (1)

43547-554-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-554-03)

Ingredients (1)

ropinirole (2 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": "9bbec058-00a5-4353-bd58-426ddb0b2020", "openfda": {"nui": ["N0000000117", "N0000175768"], "upc": ["0343547554033", "0343547557034", "0343547556037", "0343547555030", "0343547558031"], "unii": ["030PYR8953"], "rxcui": ["799054", "799055", "799056", "824959", "848582"], "spl_set_id": ["213dd2f4-4a71-456c-b3c7-b709c7bd7445"], "pharm_class_epc": ["Nonergot Dopamine Agonist [EPC]"], "pharm_class_moa": ["Dopamine Agonists [MoA]"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-554-03)", "package_ndc": "43547-554-03", "marketing_start_date": "20220322"}], "brand_name": "ROPINIROLE", "product_id": "43547-554_9bbec058-00a5-4353-bd58-426ddb0b2020", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "43547-554", "generic_name": "ropinirole", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROPINIROLE", "active_ingredients": [{"name": "ROPINIROLE", "strength": "2 mg/1"}], "application_number": "ANDA204413", "marketing_category": "ANDA", "marketing_start_date": "20220322", "listing_expiration_date": "20261231"}