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United States · US · US:76346-654_4b30c5df-70a3-418c-b2f4-26ab504eb0a3

Mifepristone

Orange BookUNIISPLATC G03XB01

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

Identification

ManufacturerCorcept Therapeutics Incorporated
CountryUS (United States)
ATC codeG03XB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7634665403
    280 TABLET in 1 BOTTLE (76346-654-03)

Annotations

UNII (FDA Substance ID)
320T6RNW1F
MIFEPRISTONE
RxCUI 6964
Orange Book
N202107
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "320T6RNW1F",
    "rxcui": "6964",
    "inchikey": "VKHAHZOOUSRJNA-GCNJZUOMSA-N",
    "display_name": "MIFEPRISTONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "839d7a7d-de19-42bd-8810-132b3c2a5daf": {
      "match": "brand_token",
      "title": "MIFEPRISTONE TABLET [EVITA SOLUTIONS LLC]",
      "spl_version": "5",
      "published_date": "2026-02-24"
    }
  },
  "productid": "76346-654_4b30c5df-70a3-418c-b2f4-26ab504eb0a3",
  "productndc": "76346-654",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202107",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "001",
        "approval_date": "Feb 17, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIFEPRISTONE",
  "proprietary_name": "Mifepristone",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA202107",
  "marketing_category": "NDA",
  "nonproprietary_name": "Mifepristone",
  "start_marketing_date": "20240528",
  "active_numerator_strength": "300"
}

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