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United States · US · US:43393-001_38fb9b4e-422b-35d9-e063-6394a90a8300

Mifepristone

Orange BookUNIISPLATC G03XB01

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

Identification

ManufacturerGenBioPro, Inc.
CountryUS (United States)
ATC codeG03XB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4339300106
    6 CARTON in 1 PACKAGE (43393-001-06) / 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (43393-001-01)

Annotations

UNII (FDA Substance ID)
320T6RNW1F
MIFEPRISTONE
RxCUI 6964
Orange Book
A091178
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": "43393-001_38fb9b4e-422b-35d9-e063-6394a90a8300",
  "productndc": "43393-001",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091178",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Apr 11, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIFEPRISTONE",
  "proprietary_name": "Mifepristone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091178",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MIFEPRISTONE",
  "start_marketing_date": "20190501",
  "active_numerator_strength": "200"
}

Related drugs

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