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United States · US · US:0254-3035_44d74b79-7146-42ef-ace2-fa64cffeb041
TIOPRONIN
Orange BookUNIISPLATC G04BX16
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeG04BX16
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11025430350990 TABLET, DELAYED RELEASE in 1 BOTTLE (0254-3035-09)
Annotations
UNII (FDA Substance ID)
C5W04GO61S
TIOPRONIN
RxCUI 6765
Orange Book
A217219
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": {
"ce5b1f97-5b3c-40b6-b1c4-1d36025be1b8": {
"match": "brand_token",
"title": "TIOPRONIN TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]",
"spl_version": "8",
"published_date": "2025-11-17"
}
},
"productid": "0254-3035_44d74b79-7146-42ef-ace2-fa64cffeb041",
"productndc": "0254-3035",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "217219",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Feb 24, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Feb 24, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIOPRONIN",
"proprietary_name": "TIOPRONIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217219",
"marketing_category": "ANDA",
"nonproprietary_name": "TIOPRONIN",
"start_marketing_date": "20240626",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code G04BX16.
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