ropinirole

Generic: ropinirole

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropinirole
Generic Name ropinirole
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ropinirole hydrochloride 2 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0631
Product ID 71335-0631_ae5d1a22-5d4f-4279-b24e-00a1a54ca7ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090135
Listing Expiration 2026-12-31
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 713350631
Hyphenated Format 71335-0631

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 ANDA090135 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71335-0631-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71335-0631-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71335-0631-3)
source: ndc

Packages (3)

71335-0631-1 30 TABLET, FILM COATED in 1 BOTTLE (71335-0631-1) 71335-0631-2 60 TABLET, FILM COATED in 1 BOTTLE (71335-0631-2) 71335-0631-3 90 TABLET, FILM COATED in 1 BOTTLE (71335-0631-3)

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": "ae5d1a22-5d4f-4279-b24e-00a1a54ca7ea", "openfda": {"unii": ["D7ZD41RZI9"], "rxcui": ["312847"], "spl_set_id": ["c89f68e5-d2ad-4aad-a63c-c32eff5e82c9"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-0631-1)", "package_ndc": "71335-0631-1", "marketing_start_date": "20240524"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-0631-2)", "package_ndc": "71335-0631-2", "marketing_start_date": "20240524"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-0631-3)", "package_ndc": "71335-0631-3", "marketing_start_date": "20240524"}], "brand_name": "ropinirole", "product_id": "71335-0631_ae5d1a22-5d4f-4279-b24e-00a1a54ca7ea", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "71335-0631", "generic_name": "ropinirole", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ropinirole", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA090135", "marketing_category": "ANDA", "marketing_start_date": "20100225", "listing_expiration_date": "20261231"}