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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
- ndc1143393001066 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
Other records sharing ATC code G03XB01.
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