ropinirole

Generic: ropinirole

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

Drug Facts

Product Profile

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

ropinirole hydrochloride 12 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-111
Product ID 62332-111_b8766b5b-290d-4ecb-8a5c-77a3ab4cb3b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202786
Listing Expiration 2027-12-31
Marketing Start 2020-06-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62332111
Hyphenated Format 62332-111

Supplemental Identifiers

RxCUI
799054 799055 799056 824959 848582
UPC
0362332107308 0362332111305 0362332110308 0362332109302
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
  • 12 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (62332-111-10)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-111-30)
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-111-31)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-111-71)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-111-90)
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-111-91)
source: ndc

Packages (6)

62332-111-10 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (62332-111-10) 62332-111-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-111-30) 62332-111-31 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-111-31) 62332-111-71 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-111-71) 62332-111-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-111-90) 62332-111-91 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-111-91)

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": "b8766b5b-290d-4ecb-8a5c-77a3ab4cb3b9", "openfda": {"upc": ["0362332107308", "0362332111305", "0362332110308", "0362332109302"], "unii": ["D7ZD41RZI9"], "rxcui": ["799054", "799055", "799056", "824959", "848582"], "spl_set_id": ["54fb15b7-da35-4841-ba5d-ee3712cd94f3"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (62332-111-10)", "package_ndc": "62332-111-10", "marketing_start_date": "20200620"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-111-30)", "package_ndc": "62332-111-30", "marketing_start_date": "20200620"}, {"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-111-31)", "package_ndc": "62332-111-31", "marketing_start_date": "20200620"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-111-71)", "package_ndc": "62332-111-71", "marketing_start_date": "20200620"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-111-90)", "package_ndc": "62332-111-90", "marketing_start_date": "20200620"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-111-91)", "package_ndc": "62332-111-91", "marketing_start_date": "20200620"}], "brand_name": "Ropinirole", "product_id": "62332-111_b8766b5b-290d-4ecb-8a5c-77a3ab4cb3b9", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "62332-111", "generic_name": "Ropinirole", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ropinirole", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": "12 mg/1"}], "application_number": "ANDA202786", "marketing_category": "ANDA", "marketing_start_date": "20200620", "listing_expiration_date": "20271231"}