ropinirole

Generic: ropinirole

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ropinirole hydrochloride .25 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-416
Product ID 72189-416_2c4cfec2-fee0-e007-e063-6294a90a3cf9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090135
Listing Expiration 2026-12-31
Marketing Start 2023-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189416
Hyphenated Format 72189-416

Supplemental Identifiers

RxCUI
312845
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
  • .25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-416-30)
source: ndc

Packages (1)

72189-416-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-416-30)

Ingredients (1)

ropinirole hydrochloride (.25 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": "2c4cfec2-fee0-e007-e063-6294a90a3cf9", "openfda": {"unii": ["D7ZD41RZI9"], "rxcui": ["312845"], "spl_set_id": ["f3a9982a-015a-1134-e053-2a95a90ad2d4"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-416-30)", "package_ndc": "72189-416-30", "marketing_start_date": "20230201"}], "brand_name": "Ropinirole", "product_id": "72189-416_2c4cfec2-fee0-e007-e063-6294a90a3cf9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "72189-416", "generic_name": "Ropinirole", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ropinirole", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": ".25 mg/1"}], "application_number": "ANDA090135", "marketing_category": "ANDA", "marketing_start_date": "20230201", "listing_expiration_date": "20261231"}