ropinirole

Generic: ropinirole

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

Drug Facts

Product Profile

Brand Name ropinirole
Generic Name ropinirole
Labeler marlex pharmaceuticals inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ropinirole hydrochloride .5 mg/1

Manufacturer
Marlex Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 10135-674
Product ID 10135-674_441e0572-3413-1a21-e063-6294a90a8e6a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079165
Listing Expiration 2026-12-31
Marketing Start 2019-03-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135674
Hyphenated Format 10135-674

Supplemental Identifiers

RxCUI
283858 312845 312846 312847 312849 314208 562704
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 ANDA079165 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (10135-674-01)
source: ndc

Packages (1)

10135-674-01 100 TABLET, FILM COATED in 1 BOTTLE (10135-674-01)

Ingredients (1)

ropinirole hydrochloride (.5 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": "441e0572-3413-1a21-e063-6294a90a8e6a", "openfda": {"unii": ["D7ZD41RZI9"], "rxcui": ["283858", "312845", "312846", "312847", "312849", "314208", "562704"], "spl_set_id": ["35d90f6f-3116-4afa-be2d-b65c160e8ab3"], "manufacturer_name": ["Marlex Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (10135-674-01)", "package_ndc": "10135-674-01", "marketing_start_date": "20190315"}], "brand_name": "Ropinirole", "product_id": "10135-674_441e0572-3413-1a21-e063-6294a90a8e6a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "10135-674", "generic_name": "ropinirole", "labeler_name": "Marlex Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ropinirole", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": ".5 mg/1"}], "application_number": "ANDA079165", "marketing_category": "ANDA", "marketing_start_date": "20190315", "listing_expiration_date": "20261231"}