ropinirole

Generic: ropinirole

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

Drug Facts

Product Profile

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

ropinirole hydrochloride .5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3478
Product ID 70518-3478_4c9d34b8-c7bd-a9fa-e063-6294a90aad46
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090135
Listing Expiration 2027-12-31
Marketing Start 2022-08-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183478
Hyphenated Format 70518-3478

Supplemental Identifiers

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
  • .5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3478-0)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-3)
source: ndc

Packages (4)

70518-3478-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3478-0) 70518-3478-1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-1) 70518-3478-2 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-2) 70518-3478-3 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-3)

Ingredients (1)

ropinirole hydrochloride (.5 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": "4c9d34b8-c7bd-a9fa-e063-6294a90aad46", "openfda": {"unii": ["D7ZD41RZI9"], "spl_set_id": ["16752e1b-10eb-4c31-92d4-ff6c6e8466f4"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3478-0)", "package_ndc": "70518-3478-0", "marketing_start_date": "20220817"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-1)", "package_ndc": "70518-3478-1", "marketing_start_date": "20230220"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-2)", "package_ndc": "70518-3478-2", "marketing_start_date": "20250618"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-3)", "package_ndc": "70518-3478-3", "marketing_start_date": "20260309"}], "brand_name": "ropinirole", "product_id": "70518-3478_4c9d34b8-c7bd-a9fa-e063-6294a90aad46", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "70518-3478", "generic_name": "ropinirole", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ropinirole", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA090135", "marketing_category": "ANDA", "marketing_start_date": "20220817", "listing_expiration_date": "20271231"}