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United States · US · US:64896-402_550f6797-b388-4ceb-885c-ef56f48ae06c
ONGENTYS
Orange BookUNIISPLATC N04BX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeN04BX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11648964020130 CAPSULE in 1 BOTTLE (64896-402-01)
Annotations
UNII (FDA Substance ID)
Y5929UIJ5N
OPICAPONE
RxCUI 2362167
Orange Book
N212489
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Y5929UIJ5N",
"rxcui": "2362167",
"inchikey": "ASOADIZOVZTJSR-UHFFFAOYSA-N",
"display_name": "OPICAPONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a511a531-112e-43f8-a43f-5334b0efe979": {
"match": "brand_token",
"title": "ONGENTYS (OPICAPONE) CAPSULE [AMNEAL PHARMACEUTICALS LLC]",
"spl_version": "9",
"published_date": "2025-11-17"
}
},
"productid": "64896-402_550f6797-b388-4ceb-885c-ef56f48ae06c",
"productndc": "64896-402",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "212489",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "25MG",
"product_no": "001",
"approval_date": "Apr 24, 2020"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "50MG",
"product_no": "002",
"approval_date": "Apr 24, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OPICAPONE",
"proprietary_name": "ONGENTYS",
"active_ingred_unit": "mg/1",
"application_number": "NDA212489",
"marketing_category": "NDA",
"nonproprietary_name": "opicapone",
"start_marketing_date": "20240405",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N04BX04.
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