ropinirole

Generic: ropinirole

Labeler: elite laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropinirole
Generic Name ropinirole
Labeler elite laboratories, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

ropinirole hydrochloride 12 mg/1

Manufacturer
Elite Laboratories, Inc.

Identifiers & Regulatory

Product NDC 64850-254
Product ID 64850-254_0ca68ebf-b908-4be4-a1a0-f9b3359375a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217862
Listing Expiration 2026-12-31
Marketing Start 2025-11-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64850254
Hyphenated Format 64850-254

Supplemental Identifiers

RxCUI
799054 799055 799056 824959 848582
UPC
0364850251303 0364850254304 0364850252300 0364850253307 0364850250306
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 (source: ndc)
Generic Name ropinirole (source: ndc)
Application Number ANDA217862 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (64850-254-30)
source: ndc

Packages (1)

64850-254-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (64850-254-30)

Ingredients (1)

ropinirole hydrochloride (12 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": "0ca68ebf-b908-4be4-a1a0-f9b3359375a4", "openfda": {"upc": ["0364850251303", "0364850254304", "0364850252300", "0364850253307", "0364850250306"], "unii": ["D7ZD41RZI9"], "rxcui": ["799054", "799055", "799056", "824959", "848582"], "spl_set_id": ["307411be-1c4e-44f7-b94d-737a3384c107"], "manufacturer_name": ["Elite Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (64850-254-30)", "package_ndc": "64850-254-30", "marketing_start_date": "20251110"}], "brand_name": "Ropinirole", "product_id": "64850-254_0ca68ebf-b908-4be4-a1a0-f9b3359375a4", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "64850-254", "generic_name": "Ropinirole", "labeler_name": "Elite Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ropinirole", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": "12 mg/1"}], "application_number": "ANDA217862", "marketing_category": "ANDA", "marketing_start_date": "20251110", "listing_expiration_date": "20261231"}