🇺🇸
United States · US · US:43063-871_3a2162b5-df74-1461-e063-6394a90a5e81
Ursodiol
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114306387101100 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-01)
- ndc11430638716060 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-60)
- ndc114306387193180 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-93)
Annotations
UNII (FDA Substance ID)
3D089V7L0K
URSADIOL
RxCUI 2045735
Orange Book
A210707
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3D089V7L0K",
"rxcui": "2045735",
"inchikey": "RTLXJEJRLWILSU-GWNGJUQLSA-N",
"display_name": "URSADIOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"fb317988-a4e3-9c9a-e053-6294a90a5990": {
"match": "brand_token",
"title": "URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "4",
"published_date": "2026-06-01"
}
},
"productid": "43063-871_3a2162b5-df74-1461-e063-6394a90a5e81",
"productndc": "43063-871",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "210707",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "001",
"approval_date": "May 17, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "URSADIOL",
"proprietary_name": "Ursodiol",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210707",
"marketing_category": "ANDA",
"nonproprietary_name": "Ursosiol",
"start_marketing_date": "20180517",
"active_numerator_strength": "300"
}Access this data programmatically
Query Ursodiol 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.