ropinirole

Generic: ropinirole

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropinirole
Generic Name ropinirole
Labeler accord healthcare inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ropinirole hydrochloride 2 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-235
Product ID 16729-235_23980eef-2eb5-2b74-e063-6394a90a68ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204022
Listing Expiration 2026-12-31
Marketing Start 2018-10-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729235
Hyphenated Format 16729-235

Supplemental Identifiers

RxCUI
283858 312845 312846 312847 312849 314208 562704
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 ANDA204022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (16729-235-01)
source: ndc

Packages (1)

16729-235-01 100 TABLET, FILM COATED in 1 BOTTLE (16729-235-01)

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": "23980eef-2eb5-2b74-e063-6394a90a68ac", "openfda": {"unii": ["D7ZD41RZI9"], "rxcui": ["283858", "312845", "312846", "312847", "312849", "314208", "562704"], "spl_set_id": ["4a2a5b63-5b14-6975-e054-00144ff8d46c"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16729-235-01)", "package_ndc": "16729-235-01", "marketing_start_date": "20181017"}], "brand_name": "ropinirole", "product_id": "16729-235_23980eef-2eb5-2b74-e063-6394a90a68ac", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "16729-235", "generic_name": "ropinirole", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ropinirole", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA204022", "marketing_category": "ANDA", "marketing_start_date": "20181017", "listing_expiration_date": "20261231"}