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United States · US · US:50742-193_b0eeccbf-775d-4ff7-805c-cc176f965198

TOLCAPONE

Orange BookUNIIATC N04BX01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerIngenus Pharmaceuticals, LLC
CountryUS (United States)
ATC codeN04BX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5074219390
    90 TABLET in 1 BOTTLE (50742-193-90)

Annotations

UNII (FDA Substance ID)
CIF6334OLY
TOLCAPONE
RxCUI 72937
Orange Book
A208937
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": "50742-193_b0eeccbf-775d-4ff7-805c-cc176f965198",
  "productndc": "50742-193",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208937",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Aug 7, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOLCAPONE",
  "proprietary_name": "TOLCAPONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208937",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tolcapone",
  "start_marketing_date": "20180821",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N04BX01.

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