Metopirone

Orange BookUNIISPLATC V04CD01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerHRA Pharma Rare Diseases

CountryUS (United States)

ATC codeV04CD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7633645518
18 CAPSULE, GELATIN COATED in 1 BOTTLE (76336-455-18)

Annotations

UNII (FDA Substance ID)

ZS9KD92H6V

METYRAPONE

RxCUI 6923

Orange Book

N012911

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "ZS9KD92H6V",
    "rxcui": "6923",
    "inchikey": "FJLBFSROUSIWMA-UHFFFAOYSA-N",
    "display_name": "METYRAPONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4046b167-7a46-8f4a-e063-6394a90a147f": {
      "match": "brand_token",
      "title": "METOPIRONE (METYRAPONE) CAPSULE, GELATIN COATED [ESTEVE PHARMACEUTICALS, S.A.]",
      "spl_version": "3",
      "published_date": "2026-05-21"
    }
  },
  "productid": "76336-455_47d0c075-05db-df45-e063-6294a90a4e12",
  "productndc": "76336-455",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "012911",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Aug 9, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METYRAPONE",
  "proprietary_name": "Metopirone",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA012911",
  "marketing_category": "NDA",
  "nonproprietary_name": "Metyrapone",
  "start_marketing_date": "19620125",
  "active_numerator_strength": "250"
}

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