Back to search
🇺🇸

United States · US · US:84670-014_4b7d82f9-da40-ce2e-e063-6294a90a92fd

Mifepristone

Orange BookUNIISPLATC G03XB01

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

Identification

ManufacturerEvita Solutions LLC
CountryUS (United States)
ATC codeG03XB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8467001401
    1 TABLET in 1 BLISTER PACK (84670-014-01)

Annotations

UNII (FDA Substance ID)
320T6RNW1F
MIFEPRISTONE
RxCUI 6964
Orange Book
A216616
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": "84670-014_4b7d82f9-da40-ce2e-e063-6294a90a92fd",
  "productndc": "84670-014",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216616",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Sep 30, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIFEPRISTONE",
  "proprietary_name": "Mifepristone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216616",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MIFEPRISTONE",
  "start_marketing_date": "20250930",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code G03XB01.

Access this data programmatically

Query Mifepristone and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.