ropinirole hydrochloride

Generic: ropinirole hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ropinirole hydrochloride 1 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-743
Product ID 50268-743_2b4c1c97-dc70-3801-e063-6394a90a7faf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078110
Listing Expiration 2026-12-31
Marketing Start 2022-08-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268743
Hyphenated Format 50268-743

Supplemental Identifiers

RxCUI
312845 312846 312847 314208
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 ANDA078110 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-743-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-743-11)
source: ndc

Packages (1)

50268-743-15 50 BLISTER PACK in 1 BOX (50268-743-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-743-11)

Ingredients (1)

ropinirole hydrochloride (1 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": "2b4c1c97-dc70-3801-e063-6394a90a7faf", "openfda": {"unii": ["D7ZD41RZI9"], "rxcui": ["312845", "312846", "312847", "314208"], "spl_set_id": ["e699a31a-25fc-554b-e053-2a95a90a843a"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-743-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-743-11)", "package_ndc": "50268-743-15", "marketing_start_date": "20220819"}], "brand_name": "ropinirole hydrochloride", "product_id": "50268-743_2b4c1c97-dc70-3801-e063-6394a90a7faf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "50268-743", "generic_name": "ropinirole hydrochloride", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ropinirole hydrochloride", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA078110", "marketing_category": "ANDA", "marketing_start_date": "20220819", "listing_expiration_date": "20261231"}