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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
- ndc117634665403280 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"
}Related drugs
Other records sharing ATC code G03XB01.
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