ropinirole

Generic: ropinirole

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropinirole
Generic Name ropinirole
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ropinirole hydrochloride .25 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6373
Product ID 0904-6373_91c699dd-e272-4845-b550-1abdd74cf9b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090429
Listing Expiration 2026-12-31
Marketing Start 2014-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046373
Hyphenated Format 0904-6373

Supplemental Identifiers

RxCUI
312845 314208
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
  • .25 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6373-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6373-61 100 BLISTER PACK in 1 CARTON (0904-6373-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "91c699dd-e272-4845-b550-1abdd74cf9b6", "openfda": {"unii": ["D7ZD41RZI9"], "rxcui": ["312845", "314208"], "spl_set_id": ["e7ef58c0-73ba-4af2-b82b-a33954ec44df"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6373-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6373-61", "marketing_start_date": "20141001"}], "brand_name": "ROPINIROLE", "product_id": "0904-6373_91c699dd-e272-4845-b550-1abdd74cf9b6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "0904-6373", "generic_name": "ROPINIROLE", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROPINIROLE", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": ".25 mg/1"}], "application_number": "ANDA090429", "marketing_category": "ANDA", "marketing_start_date": "20141001", "listing_expiration_date": "20261231"}