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United States · US · US:0178-0901_4098f871-874f-92ec-e063-6394a90af53f
Thiola EC
Orange BookUNIISPLATC G04BX16
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMission Pharmacal Company
CountryUS (United States)
ATC codeG04BX16
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11017809019090 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0901-90)
Annotations
UNII (FDA Substance ID)
C5W04GO61S
TIOPRONIN
RxCUI 6765
Orange Book
N211843
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "C5W04GO61S",
"rxcui": "6765",
"inchikey": "YTGJWQPHMWSCST-UHFFFAOYSA-N",
"display_name": "TIOPRONIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"20298a52-a194-a161-8632-d84b6f26e23c": {
"match": "brand_token",
"title": "THIOLA EC (TIOPRONIN) TABLET, DELAYED RELEASE [MISSION PHARMACAL COMPANY]",
"spl_version": "6",
"published_date": "2025-11-17"
}
},
"productid": "0178-0901_4098f871-874f-92ec-e063-6394a90af53f",
"productndc": "0178-0901",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "211843",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jun 28, 2019"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Jun 28, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIOPRONIN",
"proprietary_name": "Thiola EC",
"active_ingred_unit": "mg/1",
"application_number": "NDA211843",
"marketing_category": "NDA",
"nonproprietary_name": "tiopronin",
"start_marketing_date": "20190628",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code G04BX16.
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