ropinirole hydrochloride

Generic: ropinirole hydrochloride

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropinirole hydrochloride
Generic Name ropinirole hydrochloride
Labeler avkare
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

ropinirole hydrochloride 12 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-717
Product ID 42291-717_2b47ad1c-e1cb-7b8b-e063-6394a90aee3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090869
Listing Expiration 2026-12-31
Marketing Start 2013-09-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291717
Hyphenated Format 42291-717

Supplemental Identifiers

RxCUI
799054 799055 799056 824959 848582
UPC
0342291716308 0342291717305 0342291714304 0342291715301 0342291713307
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 ANDA090869 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-717-30)
source: ndc

Packages (1)

42291-717-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-717-30)

Ingredients (1)

ropinirole hydrochloride (12 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": "2b47ad1c-e1cb-7b8b-e063-6394a90aee3c", "openfda": {"upc": ["0342291716308", "0342291717305", "0342291714304", "0342291715301", "0342291713307"], "unii": ["D7ZD41RZI9"], "rxcui": ["799054", "799055", "799056", "824959", "848582"], "spl_set_id": ["abd344d9-7635-62a2-d4e1-38fc46937397"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-717-30)", "package_ndc": "42291-717-30", "marketing_start_date": "20231101"}], "brand_name": "ROPINIROLE HYDROCHLORIDE", "product_id": "42291-717_2b47ad1c-e1cb-7b8b-e063-6394a90aee3c", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "42291-717", "generic_name": "ropinirole hydrochloride", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROPINIROLE HYDROCHLORIDE", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": "12 mg/1"}], "application_number": "ANDA090869", "marketing_category": "ANDA", "marketing_start_date": "20130913", "listing_expiration_date": "20261231"}