ropinirole hydrochloride

Generic: ropinirole hydrochloride

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropinirole hydrochloride
Generic Name ropinirole hydrochloride
Labeler solco healthcare us, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ropinirole hydrochloride 5 mg/1

Manufacturer
SOLCO HEALTHCARE US, LLC

Identifiers & Regulatory

Product NDC 43547-601
Product ID 43547-601_bb48dd84-da25-4221-bdc7-2039e4300ed3
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 43547601
Hyphenated Format 43547-601

Supplemental Identifiers

RxCUI
283858 312845 312846 312847 312849 314208 562704
UPC
0343547601102 0343547598105 0343547596101 0343547597108 0343547599102 0343547595104 0343547600105
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 hydrochloride (source: ndc)
Generic Name ropinirole hydrochloride (source: ndc)
Application Number ANDA078110 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-601-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-601-50)
source: ndc

Packages (2)

43547-601-10 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-601-10) 43547-601-50 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-601-50)

Ingredients (1)

ropinirole hydrochloride (5 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": "bb48dd84-da25-4221-bdc7-2039e4300ed3", "openfda": {"upc": ["0343547601102", "0343547598105", "0343547596101", "0343547597108", "0343547599102", "0343547595104", "0343547600105"], "unii": ["D7ZD41RZI9"], "rxcui": ["283858", "312845", "312846", "312847", "312849", "314208", "562704"], "spl_set_id": ["5823b3a2-3256-4d94-97b4-ec6b940312f4"], "manufacturer_name": ["SOLCO HEALTHCARE US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-601-10)", "package_ndc": "43547-601-10", "marketing_start_date": "20110920"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-601-50)", "package_ndc": "43547-601-50", "marketing_start_date": "20110920"}], "brand_name": "ropinirole hydrochloride", "product_id": "43547-601_bb48dd84-da25-4221-bdc7-2039e4300ed3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "43547-601", "generic_name": "ropinirole hydrochloride", "labeler_name": "SOLCO HEALTHCARE US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ropinirole hydrochloride", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA078110", "marketing_category": "ANDA", "marketing_start_date": "20110920", "listing_expiration_date": "20261231"}