ropinirole

Generic: ropinirole

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropinirole
Generic Name ropinirole
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ropinirole hydrochloride 4 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-258
Product ID 68462-258_eaf797e1-337e-4fc1-bb49-29227b544fdb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090135
Listing Expiration 2027-12-31
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 68462258
Hyphenated Format 68462-258

Supplemental Identifiers

RxCUI
283858 312845 312846 312847 312849 314208 562704
UPC
0368462258019 0368462253014 0368462256015 0368462259016 0368462254011 0368462255018 0368462257012
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 ANDA090135 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68462-258-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68462-258-10)
source: ndc

Packages (2)

68462-258-01 100 TABLET, FILM COATED in 1 BOTTLE (68462-258-01) 68462-258-10 1000 TABLET, FILM COATED in 1 BOTTLE (68462-258-10)

Ingredients (1)

ropinirole hydrochloride (4 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": "eaf797e1-337e-4fc1-bb49-29227b544fdb", "openfda": {"upc": ["0368462258019", "0368462253014", "0368462256015", "0368462259016", "0368462254011", "0368462255018", "0368462257012"], "unii": ["D7ZD41RZI9"], "rxcui": ["283858", "312845", "312846", "312847", "312849", "314208", "562704"], "spl_set_id": ["85971b31-6f7d-421c-bf3c-5b33f3c1e781"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68462-258-01)", "package_ndc": "68462-258-01", "marketing_start_date": "20100225"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68462-258-10)", "package_ndc": "68462-258-10", "marketing_start_date": "20100225"}], "brand_name": "ropinirole", "product_id": "68462-258_eaf797e1-337e-4fc1-bb49-29227b544fdb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "68462-258", "generic_name": "ropinirole", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ropinirole", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA090135", "marketing_category": "ANDA", "marketing_start_date": "20100225", "listing_expiration_date": "20271231"}