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United States · US · US:72887-143_c28d41e2-14c2-4401-87ab-49b32239caba

Ursodiol 200 mg

In shortageOrange BookUNIISPLATC A05AA02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerFH2 Pharma LLC
CountryUS (United States)
ATC codeA05AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7288714306
    60 CAPSULE in 1 BOTTLE (72887-143-06)

Annotations

UNII (FDA Substance ID)
724L30Y2QR
URSODIOL
RxCUI 11065
Orange Book
A205789
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ursodiol Capsule
Raw payload (JSON)
{
  "unii": {
    "unii": "724L30Y2QR",
    "rxcui": "11065",
    "inchikey": "RUDATBOHQWOJDD-UZVSRGJWSA-N",
    "display_name": "URSODIOL",
    "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": "72887-143_c28d41e2-14c2-4401-87ab-49b32239caba",
  "productndc": "72887-143",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "205789",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "May 8, 2020"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "400MG",
        "product_no": "002",
        "approval_date": "May 8, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "URSODIOL",
  "shortage_reason": "Ursodiol Capsule",
  "shortage_status": "current",
  "proprietary_name": "Ursodiol 200 mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205789",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ursodiol",
  "start_marketing_date": "20211118",
  "active_numerator_strength": "200"
}

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