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United States · US · US:68118-455_522c880b-4112-b33c-e063-6294a90aa12a

Metopirone

Orange BookUNIISPLATC V04CD01

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

Identification

ManufacturerESTEVE PHARMACEUTICALS, S.A.
CountryUS (United States)
ATC codeV04CD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6811845518
    18 CAPSULE, GELATIN COATED in 1 BOTTLE (68118-455-18)

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": "68118-455_522c880b-4112-b33c-e063-6294a90aa12a",
  "productndc": "68118-455",
  "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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