ropinirole

Generic: ropinirole

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropinirole
Generic Name ropinirole
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

ropinirole hydrochloride 8 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-265
Product ID 46708-265_a1e5da4e-74fc-4482-8e15-599c665f2c2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202786
Listing Expiration 2026-12-31
Marketing Start 2013-03-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708265
Hyphenated Format 46708-265

Supplemental Identifiers

RxCUI
799054 799055 799056 824959 848582
UPC
0346708263300 0346708262303 0346708264307 0346708265304 0346708266301
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 ANDA202786 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (46708-265-10)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-30)
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-31)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-71)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-90)
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-91)
source: ndc

Packages (6)

46708-265-10 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (46708-265-10) 46708-265-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-30) 46708-265-31 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-31) 46708-265-71 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-71) 46708-265-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-90) 46708-265-91 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-91)

Ingredients (1)

ropinirole hydrochloride (8 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": "a1e5da4e-74fc-4482-8e15-599c665f2c2f", "openfda": {"upc": ["0346708263300", "0346708262303", "0346708264307", "0346708265304", "0346708266301"], "unii": ["D7ZD41RZI9"], "rxcui": ["799054", "799055", "799056", "824959", "848582"], "spl_set_id": ["2e01dbdd-f439-45d7-9085-2d92a1a1fee2"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (46708-265-10)", "package_ndc": "46708-265-10", "marketing_start_date": "20130314"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-30)", "package_ndc": "46708-265-30", "marketing_start_date": "20130314"}, {"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-31)", "package_ndc": "46708-265-31", "marketing_start_date": "20130314"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-71)", "package_ndc": "46708-265-71", "marketing_start_date": "20130314"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-90)", "package_ndc": "46708-265-90", "marketing_start_date": "20130314"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-91)", "package_ndc": "46708-265-91", "marketing_start_date": "20130314"}], "brand_name": "Ropinirole", "product_id": "46708-265_a1e5da4e-74fc-4482-8e15-599c665f2c2f", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "46708-265", "generic_name": "Ropinirole", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ropinirole", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA202786", "marketing_category": "ANDA", "marketing_start_date": "20130314", "listing_expiration_date": "20261231"}