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
Routes
ORAL
Active Ingredients

ropinirole hydrochloride 5 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-036
Product ID 62332-036_061e4779-5a53-4782-bb85-03abe1c98ce1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090429
Listing Expiration 2026-12-31
Marketing Start 2016-01-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62332036
Hyphenated Format 62332-036

Supplemental Identifiers

RxCUI
283858 312845 312846 312847 312849 314208 562704
UPC
0362332031313 0362332032310 0362332035311 0362332033317 0362332034314 0362332036318 0362332030316
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 ANDA090429 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (62332-036-31)
source: ndc

Packages (1)

62332-036-31 100 TABLET, FILM COATED in 1 BOTTLE (62332-036-31)

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": "061e4779-5a53-4782-bb85-03abe1c98ce1", "openfda": {"upc": ["0362332031313", "0362332032310", "0362332035311", "0362332033317", "0362332034314", "0362332036318", "0362332030316"], "unii": ["D7ZD41RZI9"], "rxcui": ["283858", "312845", "312846", "312847", "312849", "314208", "562704"], "spl_set_id": ["6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (62332-036-31)", "package_ndc": "62332-036-31", "marketing_start_date": "20160129"}], "brand_name": "ROPINIROLE", "product_id": "62332-036_061e4779-5a53-4782-bb85-03abe1c98ce1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "62332-036", "generic_name": "ROPINIROLE", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROPINIROLE", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090429", "marketing_category": "ANDA", "marketing_start_date": "20160129", "listing_expiration_date": "20261231"}