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
Routes
ORAL
Active Ingredients

ropinirole hydrochloride 1 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-032
Product ID 46708-032_aad4b153-ed5a-4781-ba0f-fb4bcf990057
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090429
Listing Expiration 2026-12-31
Marketing Start 2013-09-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708032
Hyphenated Format 46708-032

Supplemental Identifiers

RxCUI
283858 312845 312846 312847 312849 314208 562704
UPC
0346708030315 0346708033316 0346708036317 0346708034313 0346708032319 0346708035310 0346708031312
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
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (46708-032-31)
source: ndc

Packages (1)

46708-032-31 100 TABLET, FILM COATED in 1 BOTTLE (46708-032-31)

Ingredients (1)

ropinirole hydrochloride (1 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": "aad4b153-ed5a-4781-ba0f-fb4bcf990057", "openfda": {"upc": ["0346708030315", "0346708033316", "0346708036317", "0346708034313", "0346708032319", "0346708035310", "0346708031312"], "unii": ["D7ZD41RZI9"], "rxcui": ["283858", "312845", "312846", "312847", "312849", "314208", "562704"], "spl_set_id": ["9a25f575-09ab-4d32-b73e-5426f08c00c4"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (46708-032-31)", "package_ndc": "46708-032-31", "marketing_start_date": "20130912"}], "brand_name": "ROPINIROLE", "product_id": "46708-032_aad4b153-ed5a-4781-ba0f-fb4bcf990057", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Agonists [MoA]", "Nonergot Dopamine Agonist [EPC]"], "product_ndc": "46708-032", "generic_name": "ROPINIROLE", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROPINIROLE", "active_ingredients": [{"name": "ROPINIROLE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA090429", "marketing_category": "ANDA", "marketing_start_date": "20130912", "listing_expiration_date": "20261231"}