ropinirole

Generic: ropinirole

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropinirole
Generic Name ropinirole
Labeler coupler llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ropinirole hydrochloride 2 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1489
Product ID 67046-1489_2cdaf99a-56b8-4d61-e063-6294a90a3bc3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090429
Listing Expiration 2026-12-31
Marketing Start 2025-01-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461489
Hyphenated Format 67046-1489

Supplemental Identifiers

RxCUI
312847
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 ANDA090429 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1489-3)
source: ndc

Packages (1)

67046-1489-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1489-3)

Ingredients (1)

ropinirole hydrochloride (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": "2cdaf99a-56b8-4d61-e063-6294a90a3bc3", "openfda": {"unii": ["D7ZD41RZI9"], "rxcui": ["312847"], "spl_set_id": ["2cdae415-479b-c14c-e063-6394a90adb6c"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1489-3)", "package_ndc": "67046-1489-3", "marketing_start_date": "20250129"}], "brand_name": "ROPINIROLE", "product_id": "67046-1489_2cdaf99a-56b8-4d61-e063-6294a90a3bc3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "67046-1489", "generic_name": "ROPINIROLE", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROPINIROLE", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA090429", "marketing_category": "ANDA", "marketing_start_date": "20250129", "listing_expiration_date": "20261231"}