🇺🇸
United States · US · US:80056-143_1fc18c67-20db-4fe5-bc22-2772f0788d13
Reltone 200 mg
In shortageOrange BookUNIIATC A05AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIntra-Sana Laboratories
CountryUS (United States)
ATC codeA05AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118005614301100 CAPSULE in 1 BOTTLE (80056-143-01)
Annotations
UNII (FDA Substance ID)
724L30Y2QR
URSODIOL
RxCUI 11065
Orange Book
A205789
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",
"productid": "80056-143_1fc18c67-20db-4fe5-bc22-2772f0788d13",
"productndc": "80056-143",
"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": "Reltone 200 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA205789",
"marketing_category": "ANDA",
"nonproprietary_name": "Ursodiol",
"start_marketing_date": "20200701",
"active_numerator_strength": "200"
}Related drugs
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