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United States · US · US:68682-938_9ec63a14-0b6a-47eb-9258-19b6e3cb5b25
Tolcapone
Orange BookUNIIATC N04BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOceanside Pharmaceuticals
CountryUS (United States)
ATC codeN04BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11686829389090 TABLET, FILM COATED in 1 BOTTLE (68682-938-90)
Annotations
UNII (FDA Substance ID)
CIF6334OLY
TOLCAPONE
RxCUI 72937
Orange Book
N020697
Raw payload (JSON)
{
"unii": {
"unii": "CIF6334OLY",
"rxcui": "72937",
"inchikey": "MIQPIUSUKVNLNT-UHFFFAOYSA-N",
"display_name": "TOLCAPONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"productid": "68682-938_9ec63a14-0b6a-47eb-9258-19b6e3cb5b25",
"productndc": "68682-938",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "020697",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "001",
"approval_date": "Jan 29, 1998"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "002",
"approval_date": "Jan 29, 1998"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TOLCAPONE",
"proprietary_name": "Tolcapone",
"active_ingred_unit": "mg/1",
"application_number": "NDA020697",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Tolcapone",
"start_marketing_date": "20040727",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N04BX01.
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