ropinirole hydrochloride

Generic: ropinirole hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropinirole hydrochloride
Generic Name ropinirole hydrochloride
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ropinirole hydrochloride .25 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-825
Product ID 71205-825_89e3865c-1fe1-4f29-9606-8830df4bbe53
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078110
Listing Expiration 2026-12-31
Marketing Start 2011-09-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205825
Hyphenated Format 71205-825

Supplemental Identifiers

RxCUI
312845
UPC
0371205825300
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 hydrochloride (source: ndc)
Generic Name ropinirole hydrochloride (source: ndc)
Application Number ANDA078110 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-825-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-825-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-825-90)
source: ndc

Packages (3)

71205-825-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-825-30) 71205-825-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-825-60) 71205-825-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-825-90)

Ingredients (1)

ropinirole hydrochloride (.25 mg/1)

Linked Drug Pages (1)

ropinirole hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "89e3865c-1fe1-4f29-9606-8830df4bbe53", "openfda": {"upc": ["0371205825300"], "unii": ["D7ZD41RZI9"], "rxcui": ["312845"], "spl_set_id": ["89e3865c-1fe1-4f29-9606-8830df4bbe53"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-825-30)", "package_ndc": "71205-825-30", "marketing_start_date": "20230811"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-825-60)", "package_ndc": "71205-825-60", "marketing_start_date": "20230811"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-825-90)", "package_ndc": "71205-825-90", "marketing_start_date": "20230811"}], "brand_name": "ropinirole hydrochloride", "product_id": "71205-825_89e3865c-1fe1-4f29-9606-8830df4bbe53", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "71205-825", "generic_name": "ropinirole hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ropinirole hydrochloride", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": ".25 mg/1"}], "application_number": "ANDA078110", "marketing_category": "ANDA", "marketing_start_date": "20110920", "listing_expiration_date": "20261231"}