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United States · US · US:0591-4390_57067545-4dd0-4ab0-ba97-d17d74fe7d69
Mifepristone
Orange BookUNIISPLATC G03XB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeG03XB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11059143909628 TABLET, FILM COATED in 1 BOTTLE (0591-4390-96)
Annotations
UNII (FDA Substance ID)
320T6RNW1F
MIFEPRISTONE
RxCUI 6964
Orange Book
A211436
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": "0591-4390_57067545-4dd0-4ab0-ba97-d17d74fe7d69",
"productndc": "0591-4390",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211436",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "001",
"approval_date": "Aug 3, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIFEPRISTONE",
"proprietary_name": "Mifepristone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211436",
"marketing_category": "ANDA",
"nonproprietary_name": "Mifepristone",
"start_marketing_date": "20240119",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code G03XB01.
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