ropinirole

Generic: ropinirole

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropinirole
Generic Name ropinirole
Labeler actavis pharma, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

ropinirole hydrochloride 2 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0228-3658
Product ID 0228-3658_3499549d-d3ad-4636-8234-2539c0fbfac1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090869
Listing Expiration 2026-12-31
Marketing Start 2012-08-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02283658
Hyphenated Format 0228-3658

Supplemental Identifiers

RxCUI
799054 799055 799056 824959 848582
UNII
D7ZD41RZI9

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 ANDA090869 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3658-03)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3658-09)
source: ndc

Packages (2)

0228-3658-03 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3658-03) 0228-3658-09 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3658-09)

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": "3499549d-d3ad-4636-8234-2539c0fbfac1", "openfda": {"unii": ["D7ZD41RZI9"], "rxcui": ["799054", "799055", "799056", "824959", "848582"], "spl_set_id": ["300946bf-2f83-471d-868d-9820b65c52bb"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3658-03)", "package_ndc": "0228-3658-03", "marketing_start_date": "20120823"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3658-09)", "package_ndc": "0228-3658-09", "marketing_start_date": "20120823"}], "brand_name": "Ropinirole", "product_id": "0228-3658_3499549d-d3ad-4636-8234-2539c0fbfac1", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "0228-3658", "generic_name": "Ropinirole", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ropinirole", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA090869", "marketing_category": "ANDA", "marketing_start_date": "20120823", "listing_expiration_date": "20261231"}