ropinirole

Generic: ropinirole

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropinirole
Generic Name ropinirole
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ropinirole hydrochloride 1 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-7633
Product ID 55154-7633_82ee8a91-c8ae-4ba4-a215-78bc057f0788
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090429
Listing Expiration 2026-12-31
Marketing Start 2014-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551547633
Hyphenated Format 55154-7633

Supplemental Identifiers

RxCUI
312845 314208
UPC
0055154763301
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 ANDA090429 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-7633-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-7633-0 10 BLISTER PACK in 1 BAG (55154-7633-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

ropinirole hydrochloride (1 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": "82ee8a91-c8ae-4ba4-a215-78bc057f0788", "openfda": {"upc": ["0055154763301"], "unii": ["D7ZD41RZI9"], "rxcui": ["312845", "314208"], "spl_set_id": ["7bf874a3-4d45-41ab-9796-6729f409031c"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-7633-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-7633-0", "marketing_start_date": "20141001"}], "brand_name": "ROPINIROLE", "product_id": "55154-7633_82ee8a91-c8ae-4ba4-a215-78bc057f0788", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "55154-7633", "generic_name": "ROPINIROLE", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROPINIROLE", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA090429", "marketing_category": "ANDA", "marketing_start_date": "20141001", "listing_expiration_date": "20261231"}