Ursodiol

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerKVK-Tech, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1070223701
100 CAPSULE in 1 BOTTLE (10702-237-01)

Annotations

UNII (FDA Substance ID)

3D089V7L0K

URSADIOL

RxCUI 2045735

Orange Book

A210707

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": "10702-237_351bd434-3965-1167-e063-6294a90a1530",
  "productndc": "10702-237",
  "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"
}

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