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United States · US · US:43547-558_9bbec058-00a5-4353-bd58-426ddb0b2020
ROPINIROLE
Orange BookUNIISPLATC N04BC04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSolco Healthcare US, LLC
CountryUS (United States)
ATC codeN04BC04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11435475580330 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-558-03)
- ndc11435475580990 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-558-09)
Annotations
UNII (FDA Substance ID)
030PYR8953
ROPINIROLE
RxCUI 72302
Orange Book
A204413
ABABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "030PYR8953",
"rxcui": "72302",
"inchikey": "UHSKFQJFRQCDBE-UHFFFAOYSA-N",
"display_name": "ROPINIROLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c89f68e5-d2ad-4aad-a63c-c32eff5e82c9": {
"match": "brand_token",
"title": "ROPINIROLE TABLET, FILM COATED [BRYANT RANCH PREPACK]",
"spl_version": "101",
"published_date": "2026-06-01"
}
},
"productid": "43547-558_9bbec058-00a5-4353-bd58-426ddb0b2020",
"productndc": "43547-558",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "204413",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2MG BASE",
"product_no": "001",
"approval_date": "May 11, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 4MG BASE",
"product_no": "002",
"approval_date": "May 11, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 6MG BASE",
"product_no": "003",
"approval_date": "May 11, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 8MG BASE",
"product_no": "004",
"approval_date": "May 11, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 12MG BASE",
"product_no": "005",
"approval_date": "May 11, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ROPINIROLE",
"proprietary_name": "ROPINIROLE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204413",
"marketing_category": "ANDA",
"nonproprietary_name": "ropinirole",
"start_marketing_date": "20220322",
"active_numerator_strength": "12"
}Related drugs
Other records sharing ATC code N04BC04.
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